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ORA FIELD MANAGEMENT DIRECTIVE No. 92
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PURPOSE
To establish a procedure to be followed by ALL district offices and DEIO/International and Technical Operations Branch in monitoring and processing registrations from any Center. This procedure will help assure accurate and complete Establishment Registration information in the Center files and the field's Official Establishment Inventory and Registration files.
To provide a summary of the field and headquarters responsibilities and procedures to ensure accurate and complete registration information.
BACKGROUND
The Kefauver-Harris Amendments require, among other things, that every person who owns or operates any establishment, in any state or territory engaged in manufacturing, preparation, propagation, compounding or processing of a drug or drugs shall register with the Secretary (FDA) annually.
Since the implementation of the Drug Registration regulations in 1963, the Drug Listing regulations in 1972, and the establishment of the Bureau of Biologics and the Bureau of Medical Devices within FDA, the procedures and responsibilities for maintaining the Drug Registration file have changed significantly. Since January of 1977 the Bureau of Drugs has used a staggered, January through July, registration procedure. This procedure is shown in Attachment 1. Beginning with the mailing of registration forms for calendar year 1976, the Bureau of Biologics (renamed the Center for Biologics Evaluation and Research, CBER) assumed the responsibility for mailing forms and for updating and maintaining a registration file for all blood banks and blood product handling establishments. Vaccines, allergenics and other non-blood biological manufacturers continued to register and list with the Bureau of Drugs (renamed the Center for Drugs Evaluation and Research, CDER).
In 1976, Section 510 of the Act was amended to require the annual registration of certain medical device and diagnostic product establishments and the Bureau of Medical Devices (renamed the Center for Devices and Radiological Health, CDRH) began separate registration and listing procedures. The Safe Medical Devices Act of 1990 directed FDA to establish MDR problem reporting requirements for users and distributors. To facilitate reporting by foreign manufacturers, CDRH modified 21 CFR Part 807 to require foreign manufacturers to identify a U.S. Designated Agent. Designated Agents will be required to register and list with CDRH on behalf of the foreign manufacturer.
Beginning in 1986, CDER gave the authority to the Center for Veterinary Medicine, CVM, to list Veterinary Drug products including pharmaceutical dosage forms and type A medicated articles. CDER still performs registration duties for producers of animal drug products. Also in 1986, the Second Generation Medicated Feed Program of the CVM was finalized by regulation requiring producers who utilize type A medicated articles to manufacture type B and C medicated feeds containing category II drugs to complete a Medicated Feed Application (MFA). Section 510 of the FD&C Act also requires these feed producing sites to register with CDER.
The Center for Food Safety and Applied Nutrition (CFSAN) maintains two registration systems: Cosmetics and Low Acid Canned Foods (LACF). These registration systems are not processed or handled in the same manner as other Center registration files. The cosmetic registration/ listing is strictly voluntary at this time. There is no requirement for registration. LACF registration/process filing is required by regulation [21 CFR 108.35(c)].
I. GENERAL INFORMATION ABOUT REGISTRATION
A. Registrations will be received in the district and ITOB from four sources:
1. Center for Drug Evaluation and Research (CDER): Form FDA 2656 (new registrants) Form FDA 2656e (re-registrants)
(REGISTRATION OF DRUG ESTABLISHMENTS)
2. Center for Biologics Evaluation and Research (CBER): Form 2830 (BLOOD ESTABLISHMENT AND PRODUCT LISTING) 3. Center for Devices and Radiological Health (CDRH): Form FDA 2891 (new registrants) Form FDA 2891a (re-registrants)
4. Center for Food Safety and Applied Nutrition (CFSAN) Form FDA 2541 (LACF - new registrants) Form FDA 2511 (Cosmetics voluntary)
NOTE: If the districts or ITOB receive registration or listing forms directly from the registrants, they are to be sent immediately to the appropriate Center for processing.
B. There will be two types of registrations received:
1. New Registrants - at least two date stamped copies which do not have a CF/registration number on them. CDRH and CDER will also furnish listing data. 2. Re-registrants - one copy which has a CF/registration number on it. CDRH will furnish monthly change sheets for all registrants. COPIES OF FDA FORM 2891A WILL NOT BE SENT TO THE DISTRICT OFFICE.
NOTE: The voluntary registration of cosmetic product establishments is handled by CFSAN's Office of Cosmetics and Colors, Division of Programs and Enforcement Policy (HFS-105). The Office of Cosmetics and Colors sends establishment registration forms (FDA 2511s) directly to firms requesting them and provides registration numbers (consisting of the letter "E" and 7 digits) to firms participating in the program. Copies of completed forms are sent to the appropriate district offices for establishment inventory purposes. Districts should send a copy of "Request For Additional FDA Forms" (CR-8) to firms requesting registration forms through the district office.
C. Communications between the Centers and the regional offices, districts or ITOB:
1. Division of Emergency and Investigational Operations, Investigations Branch, HFC-132, will act as liaison between the Centers and the districts to assure that the procedures and time frames as given in "District Office Responsibilities" are followed. All inquiries from the Centers and the field about district accomplishments will be directed to:
Division of Emergency and Investigational Operations
Investigations Branch
HFC-132 Telephone: (301) 443-33402. All other routine communications with the Centers (mail or telephone) about registration will be directed to:
a. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Management/Div. of Management & Budget
Product Information Management Branch, HFD-058
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 594-1086
b. Food and Drug Administration
Center for Biologics Evaluation & Research
Division of Blood Applications, HFM-375
1401 Rockville Pike
Rockville, MD 20852-1448
Telephone: (301) 827-3546
c. Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance/Division of Program Operations
Information Processing and Office Automation Branch, HFZ-307
2098 Gaither Road
Rockville, MD 20850
Telephone: (301) 594-4520
d. Food and Drug Administration
Center for Vetrinary Medicine
Division of Surveillance, HFV-210
7500 Standish Place
Rockville, MD 20855
Telephone: (301) 594-1758
e. Food and Drug Administration
Center for Food Safety and Applied Nutrition
LACF Registration Co-ordinator, HFS-618
(for Cometics - Division of Programs and Enforcement Policy, HFS-105)
200 C Street S.W.
Washington, DC 20204
Telephone: (202) 205-4231 (cosmetics)
(202) 205-5282 (LACF)
(202) 260-0136 (LACF FAX)Internet Address: LACF@FDACF.SSW.DHHS.GOV
NOTE: The Centers' registration responsibilities may be performed in whole or in part by outside contractors. The Centers, however, still maintain staff to oversee these activities. Communications regarding registration should normally be directed to the Center's staff, not the contractors.
D. The registration number is the seven digit Central File Number (CFN) assigned to the establishment by the district or ITOB.
II. DISTRICT OFFICE AND ITOB RESPONSIBILITIES
A. General Responsibilities
1. Assign District and ITOB Registration Monitor(s).
Because the expeditious handling of the paperwork involved with the registration of establishments is of considerable importance to the Agency, each district office and ITOB has identified one or more persons as REGISTRATION MONITOR or MONITORs for the various PROGRAM areas. The monitor is the person responsible for seeing that all registrations (or registrations for their program area) are processed within the time frames involved and is the focal point for all inquiries about registration (or registration for their program area). INVESTIGATIONS BRANCH (IB), HFC-132, maintains a master roster of all monitors, by program area. These lists are in the blue pages of the Investigations Operations Manual (IOM). It is essential that IB be notified immediately when changes occur.
2. Maintain Official Establishment Inventory (OEI) File and Registration File.
Each district and ITOB is responsible for maintaining a current and accurate OEI file and Registration file. These files, in combination, should contain all current registrants that are statutory inspectional obligations, as well as the voluntary registrants. When these files are current, detailed information is available on the status of registered establishments. The Cosmetics Registration File is entirely composed of voluntary registrants.
3. Determine Status of Registrant
During the course of all inspections, it is the field's responsibility to verify the completeness and accuracy of all registration data held by FDA by determining if the registered establishment is:
a. currently registered
b. obligated to register
c. in business but not obligated to register
d. "Out of Business" (OOB)
e. "PRE-PRODUCTION REGISTRATION" or "NOT YET OPERATIONAL"
For "new" registrants, the issuing Center will send documentation of the firm's status.
4. Notify Center of Change in Status
Notify the appropriate Center or Centers promptly of the above changes in registration status and the reason for the change by submission of a copy of an FDA 481(A) and 481(E)-CG for each establishment, if it was determined during an inspection. If changes are learned of via written documentation, through phone calls to the firm and to the post office, etc. report these using an FDA-457 (Product/Establishment Surveillance Report) or your district's "Registration Change Sheet." To cancel a registration, an investigation can be done through visits, telephone calls or a combination thereof. Notification of an OOB determination must be forwarded to the appropriate Center. See also FMD 71. If a firm moves to another district, both the Center and the gaining district will be notified.
5. Monitor Late Registrants
Monitor late registrants and take appropriate action to determine their status. Encourage firms to register if required.
6. Maintain Public Information File
Maintain a Public Information File for the current calendar year of all registrants located within the district boundaries per 21 CFR Parts 207.37, 607.37, 807.37.
7. Monitor Processing of New Registrants
Assure that all work on new registrants is processed and the appropriate Center notified within FIFTEEN (15) working days after the forms are received.
B. Specific Responsibilities
1. Registration Monitor
a. For all Registrations.
See SECTION B.l.e for procedures to use for all CBER registrations received by the district for transfusion services and product testing laboratories (clinical laboratories that test blood products) inspected by the Health Care Financing Administration (HCFA).
(1) Receive registration forms from the applicable Center. For CDRH and CDER, also receive listing data for new registrants.
(2) By reviewing the documentation received (e.g. registration forms and listing information), determine whether registration is for a new registrant or a re-registrant. In addition, the documentation received should indicate:
(a) if the establishment is a licensed biologics establishment or if a license is pending. License number or "pending" will be on the FDA 2830.
(b) if the establishment is registering as a producer of human drugs, animal drugs, medicated feeds or combination of products. The monitor shall flag the registration by writing in the shaded area to the left of the control number at the top of the registration form one of the following:
HUMAN for human drugs and non-blood biologicals.
VET for veterinary drugs and medicated feeds.
HUMAN/VET for establishments that process both human and veterinary products.
(c) if a CDER registrant is operational or if it is a pre-production registration. CDRH pre-production registration forms should not be sent to the districts, if one is received contact the Center.
(d) if a CFSAN registrant is operational and has filed a registration and scheduled process. Provide a CFN and return to the appropriate division in CFSAN.
(3) After the preceding determinations are made, ensure that the data entry personnel receive the information needed to accomplish the entry of the firm into the OEI (including a determination as to whether the firm was previously registered), or updating of the registration date.
(4) Forward the yellow (or district's) copy of registration form to the district Public Information or appropriate Registration File.
b. For New Registrants
For new registrations received from a Center the monitor will process the registrations and within FIFTEEN (15) WORKING DAYS notify the appropriate Center of the results as follows:
(1) Verify that the registration is for a new establishment in the inventory, or a previously identified establishment that is registering for the first time or re-registering after a lapse in registration. Verification should be done via a check against the OEI. In the last two instances a CFN will have already been assigned and shall be used.
(2) See that the registration form, or other appropriate documentation such as an FDA 481 (Establishment Coversheet) or FDA 457 (Product/Establishment Surveillance Report) is sent to the appropriate personnel for verification and data entry.
(3) If, in the opinion of the registration monitor, the establishment does not meet the registration requirements of the regulations:
Return both copies of the registration form and documentation of the information (memo or EIR) on which the decision was based to the registration office in the appropriate Center within FIFTEEN (15) working days after the form is received in the district. DO NOT ASSIGN A REGISTRATION NUMBER to the establishment.
Indicate on the registration form "NOT REQUIRED TO REGISTER" and attach the appropriate documentation for the decision. The reasons should be clearly stated.
NOTE: There may be instances when newly registered establishments are not required to register, but are an FDA obligation under the FD&C Act. In that case, follow this procedure for the registration form returned to the Center but add the establishment to the OEI as any other non-registered obligation would be added. If they wish to voluntarily register, see SECTION II. B. 2. a. of this FMD.
(4) If a duplicate registration form for an establishment is received:
Return both copies of the form to the appropriate Center within THIRTY (30) working days after receipt. Before returning the copies write the registration number of the earlier registration and the words DUPLICATE REGISTRATION RECEIVED on both copies of the form. No other action is required.
c. For New Registrants Discovered by Inspection/Inquiry
When the district's Investigations Branch or ITOB decides that an establishment, not previously registered, must register, it shall forward the necessary information to the monitor.
(1) After screening for past registration, cancellation and other applicable information, the monitor (or other appropriate personnel) shall send the necessary registration form (all copies) with a cover letter to the establishment. Alternately, the information and forms can be provided during the inspection and documented as being provided in the EIR. The registration monitor should periodically verify that the District Office has the most current versions of the registration forms and instructions. Districts should consider using Center contacts for mailing out registration forms and packets of information to industry. The contacts for CDER, CBER, CFSAN and CDRH are as follows:
(a) CDRH, Publications
Division of Small Manufacturers Assistance, HFZ-220
1350 Piccard Drive
Rockville, MD 20850
(800) 638-2041 ext. 102 or (301) 443-7491 ext. 102
FAX (301) 443-8818NOTE: This is an automated publications request line. Caller must leave name, address, phone number and publications needed. A quicker response can be obtained by making a FAX request.
(b) Food and Drug Administration
Center for Biologics Evaluation and Research
Division of Blood Applications, HFM-375
1401 Rockville Pike
Rockville, MD 20852-1448
Telephone: (301) 827-3546
(c) Food and Drug Administration
Center for Drug Evaluation and Research
Office of Management/Division of Management and Budget
Product Information Management Branch, HFD-058
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 594-1086
(d) Food and Drug Administration
Center for Veterinary Medicine
Division of Surveillance, HFV-210
7500 Standish Place
Rockville, MD 20855
Telephone: (301) 594-1758
(e) Food and Drug Administration
Center for Food Safety and Applied Nutrition
LACF Registration Co-Ordinator, HFS-618 (for Cosmetics - Division of Programs and Enforcement Policy, HFS-105)
200 C Street S.W.
Washington D.C. 20204
Telephone: (202) 205-4231 (cosmetics)
(202) 205-5282 (LACF)
(202) 260-0136 (LACF FAX)Internet Address: LACF@FDACF.SSW.DHHS.GOV
(2) One copy of the cover letter is to be retained in the official establishment file.
(3) During the next investigation or file review, it will be verified that the firm has registered.
NOTE: If a firm has been told of the need to register or re-register and follow-up by the district reveals that the firm has not done so, the appropriate Center should be contacted to determine what action, if any, should be taken.
d. For Re-registrants
The monitor shall see that the re-registrants are processed by routing the copy of all re-registrant forms to the data entry personnel for verification of CFN, and updating of establishment name, address, and status of the registrant (active, OOB, Not OEI, etc.). The Public Information Registration files will be updated by the monitor. All differences found between the local OEI and the information on the re-registration forms will be resolved per local procedures.
e. Registration of Blood Establishments Eligible for HCFA Exemption
(1) CBER will review the initial submission and notify the establishment and the appropriate district if the establishment is exempt from registration under the interagency agreement with HCFA. A copy of the registration form will be sent to the district office stamped EXEMPT. If the establishment is not in the OEI-DO NOT ASSIGN A CFN TO IT. If the establishment is in the OEI, the registration record must have the code for HCFA obligation, "H" in the Voluntary Registration (Vol. Reg.) field.
(2) Although clinical laboratories are currently exempt from registration, laboratories that test blood products are encouraged to register and are subject to inspection by FDA. The registration record should have the code "V" in the Vol. Reg. field.
2. District Investigations Branch
a. New Registrants
In those cases where appropriate information has not been provided, Investigations Branch shall within TEN (10) working days, determine whether or not the establishment is required to register, either by an inspection of, or telephone conversation with, the establishment. The basic information about the status of the establishment including the types of products produced by the establishment should be given to the monitor.
NOTE: CBER verifies the fact that a blood establishment is required to register before mailing the registration to the district. Therefore the FDA 2830 does not need to be verified.
NOTE: If an establishment is a "Voluntary Registrant" because it is not required to register, but does so for its own purposes, the establishment registration form should be so marked and processed by the district data entry personnel. The appropriate Center should be notified of the firm's voluntary status.
b. Re-registrants and Other Establishments Inspected
Determine which establishments must re-register if not current.
If it is determined during an inspection that the establishment is required to register refer to SECTION II. B. 1. c. (1). If it is determined during an inspection that the establishment is required to re-register, the Investigator will provide the following information to the firm:
CBER: Telephone (301) 827-3546 or FAX (301) 827-3534 to reactivate the registration.
CDER: Telephone (301) 594-1086 or FAX (301) 594-1122 to reactivate the registration.
CDRH: FAX a letter on letterhead, signed by official correspondent to (301) 594-4528 or mail to address listed under SECTION I. C. 2. c.
NOTE: If a firm has been told of the need to register or re-register and follow-up by the district reveals that the firm has not done so, the appropriate Center should be contacted to determine what action, if any, should be taken.
c. Determine the Status of Each Registered Establishment
When the inspection of a registered establishment reveals that the establishment is not engaged in activities that require registration, flag the FDA 481(A) & (E)CG "REMOVE FROM REGISTRATION" and forward a copy to the appropriate Center, see SECTION I. C. 2. for addresses and mail codes. Specifically:
(1) For those establishments which are not required to register, but are an active FDA obligation, classify following normal procedures; flag the FDA 481 (A) & 481 (E) CG "REMOVE FROM REGISTRATION" and forward a copy to the appropriate Center. Code these as "C" in the Vol. Reg. field of the registration file. These establishments remain a part of the active OEI.
(2) For those establishments which have gone "Out of Business" since the last inspection, classify as OOB on FDA 481 (A) & 481 (E) CG and forward the original to the data entry personnel for processing with a copy to the appropriate Center.
(3) All other FDA 481s flagged "REMOVE FROM REGISTRATION" must identify the reason for removal and be forwarded to the appropriate Center(s) and to the data entry personnel for processing. Code as stated in SECTION c. (1) above.
NOTE: The Centers are the final authority for cancellation of registrations. If the Center does not agree with the decision to cancel the registration, the Center will notify the monitor.
(4) If it is apparent that the establishment knew when they re-registered that they were not required to register but are doing so voluntarily, DO NOT send a copy of the FDA 481 to the Center but make certain that the Registration record is flagged as a voluntary registrant ("V" in Vol. Reg. field of registration file).
d. Other Changes
The district shall submit documentation (e.g. coversheet, change sheet, OEI Improvement form, etc.) to the Center regarding all changes to name, address or establishment type. If a firm moves to another district, the gaining district shall be notified with appropriate documentation by the losing district.
3. Data Entry Personnel
a. Data entry personnel shall assign CF/registration numbers to all establishments requiring one. If the establishment has had, or currently has, a CFN on record, DO NOT assign a new number. USE THE OLD NUMBER. Remember, one establishment, one CF/registration number even if the establishment must register with CDER, CBER, CDRH, and CVM. Methadone clinics and some bio-research establishments are exceptions to this rule. FMD 130 explains the assignment of CFNs in detail.
REMEMBER: WHERE SEPARATE CORPORATE ENTITIES EXIST AT EXACTLY THE SAME GEOGRAPHICAL LOCATION (I.E. STREET ADDRESS) SEPARATE CF/REGISTRATION NUMBERS MUST BE ASSIGNED TO EACH UNIQUE CORPORATE ENTITY.
b. Data entry personnel shall ensure that for each registrant there is an OEI record and a registration record entered into the appropriate data files. The headquarters files will be updated from the current district files.
c. For re-registrants, data entry personnel shall ascertain that three years of registration dates are shown on the registration file for those establishments that have been registered for three or more years. The registration date is stamped or written in the validation block of each registration form. Forward the verified registration form to the district's Public Information or Registration File.
d. Data entry personnel shall enter the following information in the Registration file as appropriate.
(1) After the Home District and CFN are entered, enter the Center registration code:
Biologic establishments shall be identified by a "B"
Drug establishments shall be identified by a "D"
Medical Device establishments shall be identified by a "M"
Veterinary Medicine establishments shall be identified by a "V"
Food (and Cosmetic) establishments shall be identified by a "F"
(2) Military blood establishments shall be identified with an "M" in the Biologics Vol. Reg. field.
(3) Biologic establishments with a pending license shall be identified with a "P" in the Licensed field. When actually licensed, they will be identified with an "L" in the Licensed field.
(4) HCFA registrants which remain on the file will have "H" in the Biologics Vol. Reg. field. If a HCFA obligated firm returns as an FDA obligation, the "H" should be removed from the Vol. Reg. field and the file moved from AUX to Active OEI.
(5) Voluntary registrants shall be identified by a "V" in the Vol. Reg. field for the Center involved, on the registration record.
(6) Establishments flagged by the monitor "HUMAN/VET" will have entries in both the Drugs registration field and the CVM registration field. The registration date will be the same for both Centers.
See the Data Codes Manual, OEI Section and FMD 130, OEI Development and Maintenance Procedures for further registration codes and detailed registration procedures.
4. Compliance Branch
Compliance Branch has the responsibility for initiating appropriate regulatory action as set forth in the Compliance Policy Guides Manual, March 1995, Chapter 2, (Biologics, 7134.01), Chapter 4 (Drugs-General, 7132.07), and Chapter 6 (Veterinary Medicine, 7125.25) against those establishments which fail to register or to re-register in accordance with the law.
5. Management and Program Support Branch
The Management and Program Support Branch has the responsibility for maintaining an accurate Public Information File of current registrants.
III. ORA Headquarters Responsibilities
A. Division of Emergency and Investigational Operations, INVESTIGATIONS BRANCH, HFC-132, will act as liaison between the Centers and the districts to assure that the procedures and time frames as given in the District Office Responsibilities are followed. All inquiries from the Centers and the field about registration procedures will be directed to:
Investigations Branch, HFC-132
Telephone: 301-443-3340B. Investigations Branch, HFC-132 shall maintain the master roster of all district registration monitors by program area. (See SECTION II. A. l.).
C. All registration problems that are not subject matter related and are related to the mechanics of data processing should be referred to:
Office of Resource Management
Division of Information Systems, HFC-30
Telephone: 301-443-1314D. International and Technical Operations Branch, HFC-133 will function as the district office for all foreign firms and perform the duties described in this FMD under SECTION II. District Responsibilities.
IV. Center Responsibilities
A. Annual mailing of registration forms to all current registrants so that they may re-register for the current year (CDER, CBER) or the succeeding year (CDRH).
1. Any drug registration form not received in CDER three months after mailing to the establishment under the staggered registration procedures shall be considered late.
2. Any blood bank registration form not received by CBER by the end of February shall be considered late.
3. All Centers will provide the field offices with listings identifying late or changed registrations.
4. If the Center is unable to meet their scheduled timelines as specified in Attachment 1, they will notify the registration monitors.
B. Upon receipt of completed registration forms from the re-registrants, the Centers shall review all registrations for completeness and legibility, validate, and distribute the copies as follows:
1. The original shall be maintained in the Registration Section of the Center as the Administration Public Information File copy.
2. The re-registrant receives a validated copy of the re-registration.
NOTE: CDRH does not validate nor return a copy to the re-registrant. The re-registrant retains a portion of the original form prior to mailing to CDRH.
3. All changes received by the Center will be communicated to the districts via appropriate documentation. These changes may be documented via codes on the registration form (e.g. CDER Form 2656 - K: change in name of firm; L: change in site address; N: owner or operator change; R: re-entry into business with same name; S: change in name(s) of owners, partners, officers, etc. or Form 2656e) or via a change sheet (e.g. CDRH computer generated change sheets). IF THE CHANGE IS A MOVE BY THE FIRM FROM ONE DISTRICT TO ANOTHER, THE CENTER WILL PROVIDE DOCUMENTATION TO BOTH THE GAINING AND LOSING DISTRICTS.
C. Upon receipt of a completed registration form from a new registrant, the Centers shall:
1. Make sure that the original registration form is held in a pending chronological file.
2. Forward a copy(s) to the home district of the establishment or ITOB for the assignment of a CF/registration number. CDRH and CDER will also send a copy of the listing information, if available.
NOTE: CDER and CDRH will send the minimum information necessary to allow the districts or ITOB to enter the firm into the OEI to obtain a CFN:
CDER: Establishment type; product name and product code; name, address and telephone number of site to be registered.
CDRH: Establishment type; product name and product code; product classification; name, address and telephone number of site to be registered.
3. When the field office or ITOB returns a copy of the registration form with the CF/registration number on it, the Center will then mail the validated, completed registration form to the establishment. Registration information will then be entered into the Center's registration file.
4. If the district or ITOB returns the registration copy(s) to the Center with a notation "Not Required to Register," the Center:
a. Shall review district recommendations and documentation and within fifteen (15) working days, notify the district of nonconcurrence.
b. Except for "Voluntary Registrants", if in agreement with the district the Center will notify the registrant and/or establishment within thirty (30) days by letter that they are not required to register and send a copy of the letter to the appropriate district.
c. Shall not enter the establishment into the registration file.
NOTE: If the Center has information which would contradict the district's or ITOB's decision, the facts should be brought to the attention of the district or ITOB.
D. Maintain Registration Computer files for:
1. Addition of new registrants.
2. Removal of registrants who are not required to register or are "Out of Business," following receipt of copies of FDA 481s or other appropriate forms from the field.
3. Tracking or monitoring "late" registrants, (i.e. registered for the previous year but not re-registered for the current year).
4. Supplying each district and ITOB with an updated listing, by state or country, of its registrants approximately every six months but not less than once per year.
E. Answer field inquiries regarding registration procedures and requests for drug, device or blood establishment registration and listing forms.
F. Supply each district with an adequate supply of blank registration forms whenever revised.
REFERENCES
21 CFR PARTS 207, 607, AND 807
INSPECTION OPERATIONS MANUAL, SECTION 951
INSTRUCTION PUBLICATIONS FOR REGISTRATION AND LISTING (FURNISHED UPON REQUEST BY THE APPROPRIATE CENTER)
COMPLIANCE PROGRAMS CP 7356.014, 7382.008, 7371.004 AND 7342.001
COMPLIANCE POLICY GUIDES MANUAL (March 1995), CHAPTER 4 (7132.07) DRUGS, CHAPTER 2 (7134.01) BIOLOGICS AND CHAPTER 6 (7125.25) VETERINARY MEDICINE
ATTACHMENT 1
A. CENTER FOR DRUG EVALUATION AND RESEARCH
1. THE RE-REGISTRATION MAILING FOR CDER (FORM 2656e, ANNUAL REGISTRATION OF DRUG ESTABLISHMENT) SHALL BE DONE IN ALPHABETICAL SEQUENCE (USING THE NAME OF THE PARENT COMPANY, IF ANY OR THE NAME OF THE REPORTING FIRM) FOR ALL ESTABLISHMENTS. THE SCHEDULE IS AS FOLLOWS:
LETTER MONTH OF MAILING A OR B JANUARY C, D, OR E FEBRUARY F, G, OR H MARCH I, J, K, L, OR M APRIL N, O, P, Q, OR R MAY S, OR T JUNE U, V, W, X, Y, OR Z JULY NUMERIC FIRM NAMES JULY 2. EACH MONTH CDER SHALL FURNISH EACH DISTRICT A LIST OF THE ESTABLISHMENTS TO WHICH REGISTRATIONS WERE MAILED.
3. CDER SHALL FURNISH EACH DISTRICT A LIST OF LATE REGISTRANTS FROM EACH MAILING AS FOLLOWS:
MONTH OF MAILING LATE LIST TO BE MAILED JANUARY APRIL FEBRUARY MAY MARCH JUNE APRIL JULY MAY AUGUST JUNE SEPTEMBER JULY * *IN NOVEMBER, AN ACCUMULATIVE LATE LIST IS MAILED, INCLUSIVE OF FIRMS THAT SHOULD HAVE REGISTERED IN JULY.
4. ALL OTHER TIME FRAMES AND PROCEDURES SHALL BE CONSISTENT WITH THE CONTENTS OF THIS FMD.
B. CENTER FOR BIOLOGIC EVALUATION AND RESEARCH
1. THE RE-REGISTRATION MAILING FOR CBER SHALL BE DONE FROM NOVEMBER 15 THROUGH DECEMBER 31 FOR ALL ACTIVE ESTABLISHMENTS.
2. A FAILURE TO REGISTER NOTICE WILL BE SENT TO ALL LATE REGISTRANTS IN FEBRUARY.
3. CBER WILL NOTIFY THE DISTRICTS IN MARCH OF ESTABLISHMENTS NOT YET REGISTERED.
4. ALL OTHER TIME FRAMES AND PROCEDURES SHALL BE CONSISTENT WITH THE CONTENTS OF THIS FMD.
C. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
1. THE RE-REGISTRATION MAILING FOR CDRH SHALL BE DONE IN ALPHABETICAL SEQUENCE (USING THE PARENT NAME IF ANY) FOR ALL ESTABLISHMENTS. THE SCHEDULE IS AS FOLLOWS:
LETTER MONTH OF MAILING A, B, C, D, E MARCH F, G, H, I, J, K, L, M JUNE N, O, P, Q, R AUGUST S, T, U, V, W, X, Y, Z NOVEMBER NUMERICAL NAMES MARCH 2. CDRH SHALL FURNISH A CUMULATIVE LIST OF LATE REGISTRANTS TO THE REGISTRATION MONITORS EVERY FEBRUARY.
3. ALL OTHER TIME FRAMES AND PROCEDURES SHALL BE CONSISTENT WITH THE CONTENTS OF THIS FMD.
DISTRIBUTION:
Regional Food and Drug Directors and District Directors; FDA Headquarters
Offices
ISSUED BY:
ORA/ORO/Division
of Emergency and Investigational Operations
AUTHORITY:
ORA
PUBLICATION DATE: 8/96
This page was last updated on: 05/21/99.
