[Federal Register Volume 75, Number 77 (Thursday, April 22, 2010)]
[Rules and Regulations]
[Pages 20913-20917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002, 
and 1040

[Docket No. FDA-2010-N-0010]


Center for Devices and Radiological Health; New Address 
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending procedural 
regulations that pertain to obtaining, submitting, executing, and 
filing certain documents to reflect new address information for the 
Center for Devices and Radiological Health (CDRH). All filings and 
other documents that are subject to these regulations must be directed 
to the new addresses. This action is being taken to provide accuracy 
and clarity to the agency's regulations.

DATES: This regulation is effective April 22, 2010.

FOR FURTHER INFORMATION CONTACT:  Domini Bean, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4422, Silver Spring, MD 20993-0002, 301-
796-5733.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR 
parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002, and 1040 to 
reflect new address information for certain components of the agency's 
CDRH. The changes are the result of the relocation of these offices to 
FDA's White Oak campus.
    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 update mailing addresses 
and other information, and is nonsubstantive.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

[[Page 20914]]

21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting 
and recordkeeping requirements.

21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
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 Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements, X-rays.

21 CFR Part 1002

     Electronic products, Radiation protection, Reporting and 
recordkeeping requirements.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR 
Chapter I is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 
264.

0
2. Section 1.101 is amended by revising paragraph (d)(2)(iii) to read 
as follows:


Sec.  1.101  Notification and recordkeeping.

* * * * *
    (d) * * *
    (2) * * *
    (iii) For devices--Food and Drug Administration, Center for Devices 
and Radiological Health, Division of Program Operations, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.
* * * * *

PART 801--LABELING

0
3. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
4. Section 801.430 is amended by revising the text of footnote number 1 
in paragraph (f)(2) to read as follows:


Sec.  801.430  User labeling for menstrual tampons.

* * * * *
    (f) * * *
    (2) * * *
    \1\The Director of the Federal Register approves this incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You 
may obtain a copy from the American Society for Testing and Materials 
International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, 
PA 19428-2959, 610-832-9578, www.astm.org. You may inspect a copy at 
the FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor, 
Silver Spring, MD 20993-0002, 301-796-2039, or at the National Archives 
and Records Administration (NARA). For information on the availability 
of this material at NARA, call 202-741-2139, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
* * * * *

PART 803--MEDICAL DEVICE REPORTING

0
5. The authority citation for 21 CFR part 803 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

0
6. Section 803.11 is amended by revising paragraph (c) to read as 
follows:


Sec.  803.11  What form should I use to submit reports of individual 
adverse events and where do I obtain these forms?

* * * * *
    (c) Food and Drug Administration, Center for Devices and 
Radiological Health, Division of Small Manufacturers, International and 
Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, 
Silver Spring, MD 20993-0002.
* * * * *

0
7. Section 803.21 is amended by revising paragraph (a) to read as 
follows:


Sec.  803.21  Where can I find the reporting codes for adverse events 
that I use with medical device reports?

    (a) The MEDWATCH Medical Device Reporting Code Instruction Manual 
contains adverse event codes for use with FDA Form 3500A. You may 
obtain the coding manual from CDRH's Web site at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149238.htm.
* * * * *

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
8. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

0
9. Section 807.22 is amended by revising paragraph (a) to read as 
follows:


Sec.  807.22  How and where to register establishments and list 
devices.

    (a) The first registration of a device establishment shall be on 
Form FDA-2891 (Initial Registration of Device Establishment). Forms are 
available upon request from the Food and Drug Administration, Center 
for Devices and Radiological Health, Office of Compliance, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002, or 
from Food and Drug Administration district offices. Subsequent annual 
registration shall be accomplished on Form FDA-2891a (Annual 
Registration of Device Establishment), which will be furnished by FDA 
to establishments whose registration for that year was validated under 
Sec.  807.35(a). The forms will be mailed to the owner or operators of 
all establishments by the official correspondent in accordance with the 
schedule as described in Sec.  807.21(a). The completed form shall be 
mailed to the address designated in this paragraph 30 days after 
receipt from FDA.
* * * * *

0
10. Section 807.37 is amended by revising paragraphs (a) and (b)(2) to 
read as follows:


Sec.  807.37  Inspection of establishment registration and device 
listings.

    (a) A copy of the forms FDA-2891 and FDA-2891a filed by the 
registrant will be available for inspection in

[[Page 20915]]

accordance with section 510(f) of the act, at the Food and Drug 
Administration, Center for Devices and Radiological Health, Office of 
Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver 
Spring, MD 20993-0002. In addition, there will be available for 
inspection at each of the Food and Drug Administration district offices 
the same information for firms within the geographical area of such 
district office. Upon request, verification of registration number or 
location of a registered establishment will be provided.
    (b) * * *
    (2) Requests for device listing information identified in paragraph 
(b)(1) of this section should be directed to the Food and Drug 
Administration, Center for Devices and Radiological Health, Office of 
Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver 
Spring, MD 20993-0002.
* * * * *

0
11. Section 807.90 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  807.90  Format of a premarket notification submission.

* * * * *
    (a)(1) For devices regulated by the Center for Devices and 
Radiological Health, be addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health, Document Mail Center, 10903 
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
12. 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
13. Section 812.19 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  812.19  Address for IDE correspondence.

    (a) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send it to Food and Drug Administration, Center 
for Devices and Radiological Health, Document Mail Center, 10903 New 
Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
14. 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
15. Section 814.20 is amended by revising paragraph (h)(1) to read as 
follows:


Sec.  814.20  Application.

* * * * *
    (h) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, Food and Drug Administration, Center for Devices 
and Radiological Health, Document Mail Center, 10903 New Hampshire 
Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

0
16. Section 814.104 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  814.104  Original applications.

* * * * *
    (d) * * *
    (1) For devices regulated by the Center for Devices and 
Radiological Health, send to Document Mail Center, 10903 New Hampshire 
Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 820--QUALITY SYSTEM REGULATION

0
17. The authority citation for 21 CFR part 820 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

0
18. Section 820.1 is amended by revising paragraph (e)(1) to read as 
follows:


Sec.  820.1  Scope.

* * * * *
    (e) * * * (1) Any person who wishes to petition for an exemption or 
variance from any device quality system requirement is subject to the 
requirements of section 520(f)(2) of the act. Petitions for an 
exemption or variance shall be submitted according to the procedures 
set forth in Sec.  10.30 of this chapter, the FDA's administrative 
procedures. Guidance is available from the Food and Drug 
Administration, Center for Devices and Radiological Health, Division of 
Small Manufacturers, International and Consumer Assistance, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-
800-638-2041 or 301-796-7100, FAX: 301-847-8149.
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
19. 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
20. Section 822.8 is revised to read as follows:


Sec.  822.8  When, where, and how must I submit my postmarket 
surveillance plan?

    You must submit your plan to conduct postmarket surveillance within 
30 days of the date you receive the postmarket surveillance order. For 
devices regulated by the Center for Biologics Evaluation and Research, 
send three copies of your submission 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, send three copies of your submission to the Central Document 
Room, Center for Drug Evaluation and Research, Food and Drug 
Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For 
devices regulated by the Center for Devices and Radiological Health, 
send three copies of your submission to the Document Mail Center, 10903 
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002. 
When we receive your original submission, we will send you an 
acknowledgment letter identifying the unique document number assigned 
to your submission. You must use this number in any correspondence 
related to this submission.

0
21. Section 822.12 is revised to read as follows:


Sec.  822.12  Do you have any information that will help me prepare my 
submission or design my postmarket surveillance plan?

    Guidance documents that discuss our current thinking on preparing a 
postmarket surveillance submission and designing a postmarket 
surveillance plan are available on the Center for Devices and 
Radiological Health's Web site and from the Food and Drug 
Administration, Center for Devices and Radiological Health, Office of 
Surveillance and Biometrics, 10903 New Hampshire Ave., Bldg. 66, rm. 
3219, Silver Spring, MD 20993-0002. Guidance documents represent our 
current interpretation of, or policy on, a regulatory issue. They do 
not establish

[[Page 20916]]

legally enforceable rights or responsibilities and do not legally bind 
you or FDA. You may choose to use an approach other than the one set 
forth in a guidance document, as long as your alternative approach 
complies with the relevant statutes (laws) and regulations. If you 
wish, we will meet with you to discuss whether an alternative approach 
you are considering will satisfy the requirements of the act and 
regulations.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
22. 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
23. 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, 10903 
New Hampshire Ave., Bldg. 66, rm. 4425, Silver Spring, MD 20993-0002; 
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.
* * * * *

PART 900--MAMMOGRAPHY

0
24. The authority citation for 21 CFR part 900 continues to read as 
follows:

    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

0
25. Section 900.15 is amended by revising paragraph (d)(3)(i) to read 
as follows:


Sec.  900.15  Appeals of adverse accreditation or reaccreditation 
decisions that preclude certification or recertification.

* * * * *
    (d) * * *
    (3) * * *
    (i) A facility must request reconsideration by DMQRP within 60 days 
of the accreditation body's adverse appeals decision, at the following 
address: Food and Drug Administration, Center for Devices and 
Radiological Health, Division of Mammography Quality and Radiation 
Programs, Attn: Facility Accreditation Review Committee, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.
* * * * *

0
26. Section 900.18 is amended by revising paragraph (c) introductory 
text to read as follows:


Sec.  900.18  Alternative requirements for Sec.  900.12 quality 
standards.

* * * * *
    (c) Applications for approval of an alternative standard. An 
application for approval of an alternative standard or for an amendment 
or extension of the alternative standard shall be submitted in an 
original and two copies to the Food and Drug Administration, Center for 
Devices and Radiological Health, Director, Division of Mammography 
Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 
4521, Silver Spring, MD 20993-0002. The application for approval of an 
alternative standard shall include the following information:
* * * * *

0
27. Section 900.21 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  900.21  Application for approval as a certification agency.

* * * * *
    (b) * * * (1) An applicant seeking FDA approval as a certification 
agency shall inform the Food and Drug Administration, Center for 
Devices and Radiological Health, Director, Division of Mammography 
Quality and Radiation Programs, Attn: States as Certifiers Coordinator, 
10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-
0002, in writing, of its desire to be approved as a certification 
agency.
* * * * *

PART 1002--RECORDS AND REPORTS

0
28. The authority citation for 21 CFR part 1002 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 
374.

0
29. Section 1002.7 is amended by revising the introductory text to read 
as follows:


Sec.  1002.7  Submission of data and reports.

    All submissions such as reports, test data, product descriptions, 
and other information required by this part, or voluntarily submitted 
to the Director, Center for Devices and Radiological Health, shall be 
filed with the number of copies as prescribed by the Director, Center 
for Devices and Radiological Health, and shall be signed by the person 
making the submission. The submissions required by this part shall be 
addressed to the Food and Drug Administration, Center for Devices and 
Radiological Health, ATTN: Electronic Product Reports, Document Mail 
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 
20993-0002.
* * * * *

0
30. Section 1002.10 is amended by revising the introductory text to 
read as follows:


Sec.  1002.10  Product reports.

    Every manufacturer of a product or component requiring a product 
report as set forth in table 1 of Sec.  1002.1 shall submit a product 
report to the Food and Drug Administration, Center for Devices and 
Radiological Health, ATTN: Electronic Product Reports, Document Mail 
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 
20993-0002, prior to the introduction of such product into commerce. 
The report shall be distinctly marked ``Radiation Safety Product Report 
of (name of manufacturer)'' and shall:
* * * * *

0
31. Section 1002.20 is amended by revising paragraph (b) introductory 
text to read as follows:


Sec.  1002.20  Reporting of accidental radiation occurrences.

* * * * *
    (b) Such reports shall be addressed to Food and Drug 
Administration, Center for Devices and Radiological Health, ATTN: 
Accidental Radiation Occurrence Reports, Document Mail Center, 10903 
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002, 
and the reports and their envelopes shall be distinctly marked ``Report 
on 1002.20'' and shall contain all of the following information where 
known to the manufacturer:
* * * * *

0
32. Section 1002.50 is amended by revising paragraph (c)(3) to read as 
follows:


Sec.  1002.50  Special exemptions.

* * * * *
    (c) * * *
    (3) Such conditions as are deemed necessary to protect the public 
health and safety. Copies of exemptions shall

[[Page 20917]]

be available upon request from the Food and Drug Administration, Center 
for Devices and Radiological Health, Division of Mammography Quality 
and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521, 
Silver Spring, MD 20993-0002.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
33. The authority citation for 21 CFR part 1040 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 
U.S.C. 263B-263n.

0
34. Section 1040.10 is amended by revising paragraph (a)(3)(i) to read 
as follows:


Sec.  1040.10  Laser products.

    (a) * * *
    (3) * * *
    (i) Registers, and provides a listing by type of such laser 
products manufactured that includes the product name, model number and 
laser medium or emitted wavelength(s), and the name and address of the 
manufacturer. The manufacturer must submit the registration and listing 
to the Food and Drug Administration, Center for Devices and 
Radiological Health, Director, Office of Compliance, 10903 New 
Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.
* * * * *

0
35. Section 1040.20 is amended by revising paragraph (d)(3)(iii) to 
read as follows:


Sec.  1040.20  Sunlamp products and ultraviolet lamps intended for use 
in sunlamp products.

* * * * *
    (d) * * *
    (3) * * *
    (iii) If the size, configuration, design, or function of the 
sunlamp product or ultraviolet lamp would preclude compliance with the 
requirements for any required label or would render the required 
wording of such label inappropriate or ineffective, or would render the 
required label unnecessary, the Director, Office of Communication, 
Education, and Radiation Programs 10903 New Hampshire Ave., Bldg. 66, 
rm. 4312, Silver Spring, MD 20993-0002, Center for Devices and 
Radiological Health, on the center's own initiative or upon written 
application by the manufacturer, may approve alternate means of 
providing such label(s), alternate wording for such label(s), or 
deletion, as applicable.
* * * * *

    Dated: April 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8863 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S