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[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Rules and Regulations]
[Page 49941-49943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au08-5]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16, 610, 640, 812, 814, 822, and 860
[Docket No. FDA-2008-N-0423]
FDA Regulations; 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 a
regulatory hearing process regulation to correct an inaccurate
citation, and regulations pertaining to biological products to correct
two typographical errors. FDA is also amending certain medical device
regulations to include references to and mailing address information
for the Center for Biologics Evaluation and Research (CBER), Center for
Drug Evaluation and Research (CDER), and Center for Devices and
Radiological Health (CDRH). This action is being taken to ensure the
accuracy of FDA's regulations.
DATES: This rule is effective August 25, 2008.
FOR FURTHER INFORMATION CONTACT: Denise Sanchez, 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:
I. Background
FDA is amending 21 CFR 16.1 to correct an inaccurate citation and
is amending 21 CFR 610.51 and 21 CFR 640.53 to correct typographical
errors.
FDA is also amending its medical device regulations in 21 CFR 812,
814, and 860 to include references to and mailing addresses for CBER
and CDER, and 21 CFR 822.8 to correct an inadvertent omission of the
mailing address for CDRH. Submissions regarding a medical device must
be sent to the address of the appropriate center that has regulatory
responsibility for the medical device. Therefore, FDA is updating these
regulations to include address information for all appropriate centers.
Publication of this document constitutes final action under the
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to correct an inaccurate
citation and typographical errors, and to update mailing addresses and
other information, and is nonsubstantive.
List of Subjects
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 640
Blood, Labeling, Reporting and recordkeeping requirements.
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, Reporting and
recordkeeping requirements.
21 CFR Part 822
Medical devices, Reporting and recordkeeping requirements.
21 CFR Part 860
Administrative practice and procedure, Medical devices.
0
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 16, 610, 640, 812, 814, 822, and 860
are amended as follows:
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
1. The authority citation for 21 CFR part 16 continues to read as
follows:
[[Page 49942]]
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
Sec. 16.1 [Amended]
0
2. Section 16.1 is amended in paragraph (b)(2), by removing ``Sec.
1270.15(e)'' and adding in its place ``Sec. 1270.43(e)''.
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
0
3. The authority citation for 21 CFR part 610 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
Sec. 610.53 [Amended]
0
4. Section 610.53 is amended in paragraph (c) in the table, under
column A, by removing the words ``Cryoprecipitated AFH'' and adding in
their place ``Cryoprecipitated AHF.''
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
0
5. The authority citation for 21 CFR part 640 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.
Sec. 640.51 [Amended]
0
6. Section 640.51 is amended in paragraph (b) by removing the word
``Plasmaphersis'' and adding in its place ``Plasmapheresis.''
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
7. 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.
0
8. Section 812.20 is amended by revising paragraph (d) to read as
follows:
Sec. 812.20 Application.
* * * * *
(d) Information previously submitted. Information previously
submitted to the Center for Devices and Radiological Health, the Center
for Biologics Evaluation and Research, or the Center for Drug
Evaluation and Research, as applicable, in accordance with this chapter
ordinarily need not be resubmitted, but may be incorporated by
reference.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
9. 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.
0
10. Section 814.42 is amended by revising the fourth sentence of
paragraph (d)(2) to read as follows:
Sec. 814.42 Filing a PMA.
* * * * *
(d) * * *
(2) * * * If FDA does not reverse its decision not to file the PMA,
the applicant may request reconsideration of the decision from the
Director of the Center for Devices and Radiological Health, the
Director of the Center for Biologics Evaluation and Research, or the
Director of the Center for Drug Evaluation and Research, as applicable.
* * *
* * * * *
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11. Section 814.100 is amended by revising paragraph (c)(2) to read as
follows:
Sec. 814.100 Purpose and scope.
* * * * *
(c) * * *
(2) Submitting an HDE to the Office of Device Evaluation (ODE),
Center for Devices and Radiological Health (CDRH), the Center for
Biologics Evaluation and Research (CBER), or the Center for Drug
Evaluation and Research (CDER), as applicable.
* * * * *
0
12. Section 814.104 is amended by revising paragraph (d) to read as
follows:
Sec. 814.104 Original applications.
* * * * *
(d) Address for submissions and correspondence. Copies of all
original HDEs amendments and supplements, as well as any correspondence
relating to an HDE, must be sent or delivered to the following:
(1) For devices regulated by the Center for Devices and
Radiological Health, send this information to the Document Mail Center
(HFZ-401), Office of Device Evaluation, 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 this information 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 this information to the Central Document Control Room,
Center for Drug Evaluation and Research, Food and Drug Administration,
5901-B Ammendale Rd., Beltsville, MD 20705-1266.
PART 822--POSTMARKET SURVEILLANCE
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13. The authority citation for 21 CFR part 822 continues to read as
follows:
Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
0
14. Section 822.8 is amended by adding a sentence after the first
sentence to read as follows:
Sec. 822.8 When, where, and how must I submit my postmarket
surveillance plan?
* * * For devices regulated by the Center for Devices and
Radiological Health, send three copies of your submission to the
Postmarket Surveillance Document Center (HFZ-541), Epidemiology Branch,
Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. * * *
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES
0
15. The authority citation for 21 CFR part 860 continues to read as
follows:
Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.
0
16. Section 860.7 is amended by revising paragraph (g)(4) to read as
follows:
Sec. 860.7 Determination of safety and effectiveness.
* * * * *
(g) * * *
(4) Required information that has been submitted previously to the
Center for Devices and Radiological Health, the Center for Biologics
Evaluation and Research, or the Center for Drug Evaluation and
Research, as applicable, need not be resubmitted, but may be
incorporated by reference.
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17. Section 860.123 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 860.123 Reclassification petition: Content and form.
* * * * *
(b) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff
[[Page 49943]]
(HFZ-215), 1350 Piccard Dr., Rockville, MD 20857; for devices regulated
by the Center for Biologics Evaluation and Research, addressed 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; for devices regulated by the Center for
Drug Evaluation and Research, addressed to the Central Document Control
Room, Center for Drug Evaluation and Research, Food and Drug
Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as
applicable.
* * * * *
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19654 Filed 8-22-08; 8:45 am]
BILLING CODE 4160-01-S