[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Rules and Regulations]
[Page 42048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy06-9]
[[Page 42048]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 812 and 814
[Docket No. 2006N-0284]
Medical Device Regulations; Addresses; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending certain
device regulations to include address information for the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research. These regulations pertain to the submission of certain
documents to FDA. Currently, only address information for the Center
for Devices and Radiological Health is listed in these regulations.
This action is being taken to ensure the accuracy of FDA's regulations.
DATES: This rule is effective July 25, 2006.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
parts 812 and 814 to include address information for the Center for
Biologics Evaluation and Research and the Center for Drug Evaluation
and Research. These regulations pertain to the investigational device
exemptions (IDEs) and premarket approval (PMA) of medical devices.
Currently, only the address information for the Center for Devices and
Radiological Health is listed in these regulations for the various
submissions associated with IDE applications and PMA applications. IDEs
and PMAs, and their associated submissions, must be sent to the address
of the appropriate Center that has regulatory responsibility for the
medical device. Therefore, FDA is updating its regulations to include
this address information.
Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only a technical change to update addresses in the
Code of Federal Regulations, and is nonsubstantive.
List of Subjects
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, and Reporting and
recordkeeping requirements.
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Therefore, under the Federal Food, Drug, and Cosmetic Act, and Public
Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 812 and 814 are amended as follows:
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
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1. The authority citation for 21 CFR part 812 continues to read as
follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.
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2. Section 812.19 is revised to read as follows:
Sec. 812.19 Address for IDE correspondence.
(a) If you are sending an application, supplemental application,
report, request for waiver, request for import or export approval, or
other correspondence relating to matters covered by this part, you must
send the submission to the appropriate address as follows:
(1) For devices regulated by the Center for Devices and
Radiological Health, send it to the Document Mail Center (HFZ-401),
Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the Document Control Center (HFM-99), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448.
(3) For devices regulated by the Center for Drug Evaluation and
Research, send it to Central Document Control Room, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266.
(b) You must state on the outside wrapper of each submission what
the submission is, for example, an ``IDE application,'' a
``supplemental IDE application,'' or a ``correspondence concerning an
IDE (or an IDE application).''
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
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3. The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.
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4. Section 814.20 is amended by revising paragraph (h) to read as
follows:
Sec. 814.20 Application.
* * * * *
(h) If you are sending a PMA, PMA amendment, PMA supplement, or
correspondence with respect to a PMA, you must send the submission to
the appropriate address as follows:
(1) For devices regulated by the Center for Devices and
Radiological Health, send it to: Document Mail Center (HFZ-401), Center
for Devices and Radiological Health, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to: Document Control Center (HFM-99), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
(3) For devices regulated by the Center for Drug Evaluation and
Research, send it to: Central Document Control Room, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266.
Dated: July 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11777 Filed 7-24-06; 8:45 am]
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