
[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 S[aacute]nchez, 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. 
* * *
* * * * *

0
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

0
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.

0
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
