Division of Freedom of Information; Change of Office Name, Address, Telephone Number, and Fax Number; Technical Amendments, 31468-31470 [2011-13488]
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31468
Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations
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miles per gallon or ‘‘mpg’’) as
determined by the mandatory EPA
testing protocols. If advertisers make
fuel economy claims based on non-EPA
tests, the Guide directs them to disclose
EPA-derived fuel economy information
with substantially more prominence
than other estimates 3 and provide
details about the non-EPA tests such as
the source of the test, driving
conditions, and vehicle configurations.
On April 28, 2009,4 the Commission
published a Notice of Proposed
Rulemaking (‘‘NPRM’’) soliciting
comments on proposed amendments to
the Guide. The Commission’s proposed
revisions to the Guide included: (1)
updating the Guide’s definitions and
guidance to reflect the new ‘‘combined’’
fuel economy estimates established by
the EPA’s fuel economy labeling
requirements; and (2) extending
advertising guidance to alternative
fueled vehicles based on the
Commission’s Alternative Fuels Rule.5
The Commission received eight
comments from sources including the
automobile manufacturing industry,
local government, and consumers
groups.6 Generally, the comments
supported retaining the Guide and
recognized its benefits. Several,
however, noted inconsistencies between
calculations and standards found in the
FTC’s Alternative Fuels Rule and those
established by the EPA’s fuel economy
labeling requirements.7
On September 28, 2009, during the
course of the Commission’s regulatory
review for the Guide, EPA and NHTSA
announced their ‘‘Proposed Rulemaking
To Establish Light-Duty Vehicle
Greenhouse Gas Emission Standards
and Corporate Average Fuel Economy
Standards.’’ 8 In that Federal Register
Notice, the EPA and the NHTSA
announced the creation of a ‘‘National
Program * * * to reduce greenhouse gas
emission and to improve fuel
economy.’’ 9 To fulfill the statutory
requirements of the Energy
Independence and Security Act 10 and to
conform with the goals of the National
Program, the agencies are developing
labels that ‘‘reflect fuel economy and
greenhouse gas and other emissions
* * * [and also include] a rating system
3 For audio advertisements, EPA fuel economy
estimates must be given equal prominence as nonEPA estimates. 16 CFR 259.2(c)(1).
4 74 FR 19148.
5 16 CFR Part 309.
6 Comments are available at: https://www.ftc.gov/
os/comments/fueleconadguidepropamend/
index.shtm.
7 40 CFR Part 600, subpart D.
8 74 FR 49454 (Sep. 28, 2009).
9 Id.
10 Public Law 110–140.
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that would make it easy for consumers
to compare the fuel economy and
greenhouse gas and other emissions of
automobiles at the point of purchase.’’ 11
In addition, the agencies proposed
creating their own label for alternative
fueled vehicles, and solicited comment
on proposed label formats in September
2010.12
The EPA’s proposed rulemaking
impacts both the Commission’s
Alternative Fuels Rule and its Fuel
Economy Guide. That rulemaking will
increase the coverage of EPA’s new fuel
economy labels to include alternative
fueled vehicles, many of which would
also have additional labeling
requirements under the existing
Alternative Fuels Rule. Therefore, in a
separate notice published today, the
Commission is accelerating its review of
the Alternative Fuels Rule to reduce the
potential for conflicting or redundant
labeling requirements. The result of the
Commission’s review also may affect the
guidance that the Commission would
issue to new vehicle advertisers in the
FTC’s Fuel Economy Guide. Therefore,
the Commission has determined that it
would be premature to publish
amended guidance concerning fuel
economy advertising until the EPA and
the NHTSA conclude their regulatory
reviews and the Commission completes
its Regulatory Review of the Alternative
Fuels Rule. The Commission continues
to believe that guidance in this area
would be beneficial but recognizes the
value in issuing consistent government
guidance.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2011–13519 Filed 5–31–11; 8:45 am]
BILLING CODE 6750–01–P
The Food and Drug
Administration (FDA) is amending the
Agency’s regulations to reflect changes
to the Division of Freedom of
Information’s office name, address,
telephone number, and fax number and
the Division of Freedom of Information
Public Reading room’s fax and room
number. This action is editorial in
nature and is intended to improve the
accuracy of the Agency’s regulations.
DATES: This rule is effective June 1,
2011.
SUMMARY:
Fred
Sadler, Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857, 301–796–8975.
SUPPLEMENTARY INFORMATION: FDA is
making technical amendments in the
Agency’s regulations under 21 CFR
parts 5, 10, 14, 19, 20, 21, 314, 350, 516,
and 814 as a result of a recent office
move. The former address, telephone
number, and fax number was: rm. 6–30,
Parklawn Bldg., 5600 Fishers Lane,
Rockville, MD 20857, telephone: 301–
827–6567, FAX: 301–443–1726. The
new address is: Division of Freedom of
Information (ELEM–1029), 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857, telephone: 301–796–3900,
FAX: 301–796–9267. The Division of
Freedom of Information Public Reading
Room number is 1050.
Publication of this document
constitutes final action of these changes
under the Administrative Procedures
Act (5 U.S.C. 553). FDA has determined
that notice and public comment are
unnecessary because these amendments
are merely correcting nonsubstantive
errors.
FOR FURTHER INFORMATION CONTACT:
List of Subjects
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 5, 10, 14, 19, 20, 21, 314,
350, 516, and 814
[Docket No. FDA–2011–N–0318]
Division of Freedom of Information;
Change of Office Name, Address,
Telephone Number, and Fax Number;
Technical Amendments
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
11 74
FR at 49739.
12 75 FR 58078 (Sept. 23, 2010).
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21 CFR Part 5
Authority delegations (Government
agencies), Imports, Organization and
functions (Government agencies).
21 CFR Part 10
Administrative practice and
procedure, News media.
21 CFR Part 14
Administrative practice and
procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
21 CFR Part 19
Conflict of interests.
21 CFR Part 20
Confidential business information,
Courts, Freedom of Information,
Government employees.
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21 CFR Part 21
Privacy.
place add ‘‘Division of Freedom of
Information (ELEM–1029)’’.
21 CFR Part 314
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
§ 10.95
[Amended]
6. In § 10.95, remove ‘‘Freedom of
Information Staff’’ and ‘‘Freedom of
Information Staff (HFI–35)’’ everywhere
they appear and in their places add
‘‘Division of Freedom of Information
(ELEM–1029)’’.
■
21 CFR Part 350
Labeling, Over-the-counter drugs.
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and
procedure, Confidential business
information, Medical devices, Medical
research, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 5, 10,
14, 19, 20, 21, 314, 350, 516, and 814
are amended as follows:
PART 5—ORGANIZATION
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
7. The authority citation for 21 CFR
part 14 continues to read as follows:
■
Authority: 5 U.S.C. App. 2; 15 U.S.C.
1451–1461, 21 U.S.C. 41–50, 141–149, 321–
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Pub. L. 108–155.
§ 14.65
[Amended]
8. In § 14.65(c), remove ‘‘Freedom of
Information Staff (HFI–35)’’ and in its
place add ‘‘Division of Freedom of
Information (ELEM–1029)’’.
■
PART 19—STANDARDS OF CONDUCT
AND CONFLICTS OF INTEREST
9. The authority citation for 21 CFR
part 19 continues to read as follows:
■
Authority: 21 U.S.C. 371.
1. The authority citation for 21 CFR
part 5 continues to read as follows:
■
§ 19.10
Authority: 5 U.S.C. 552; 21 U.S.C. 301–
397.
[Amended]
2. Revise § 5.1110(b) to read as
follows:
10. In § 19.10(d) introductory text,
remove ‘‘Freedom of Information Staff’’
and in its place add ‘‘Division of
Freedom of Information’’.
§ 5.1110
PART 20—PUBLIC INFORMATION
■
■
FDA public information offices.
*
*
*
*
*
(b) Division of Freedom of
Information. The Division of Freedom of
Information Public Reading Room is
located in rm. 1050, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857; Telephone: 301–796–3900.
*
*
*
*
*
11. The authority citation for 21 CFR
part 20 continues to read as follows:
■
Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19
U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–
1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b–263n, 264, 265, 300u–
300u–5, 300aa–1.
■
PART 10—ADMINISTRATIVE
PRACTICES AND PROCEDURES
Authority: 5 U.S.C. 551–558, 701–706; 15
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–
397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
[Amended]
4. In § 10.85(d)(4), remove ‘‘Freedom
of Information Staff (HFI–35)’’ and in its
place add ‘‘Division of Freedom of
Information (ELEM–1029)’’.
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§ 10.90
5. In § 10.90(d), remove ‘‘Freedom of
Information Staff (HFI–35),’’ and in its
■
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(a) The office responsible for Agency
compliance with the Freedom of
Information Act and this part is the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
(b) All requests for Agency records
shall be sent in writing to this office.
■ 15. In § 20.40, revise paragraph (a);
and in paragraph (c), remove ‘‘Freedom
of Information Staff’’ and in its place
add ‘‘Division of Freedom of
Information’’ to read as follows:
§ 20.40
Filing a request for records.
(a) All requests for Food and Drug
Administration records shall be made in
writing by mailing or delivering the
request to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857; or by faxing it to 301–796–9267.
All requests must contain the postal
address and telephone number of the
requester and the name of the person
responsible for payment of any fees that
may be charged.
*
*
*
*
*
§ 20.41
[Amended]
16. In § 20.41 paragraph (a), paragraph
(b) introductory text, and paragraph (c),
remove ‘‘Freedom of Information Staff’’
and in its place add ‘‘Division of
Freedom of Information’’.
■
§ 20.44
■
*
*
*
*
(b) A request for certified copies of
records or for authentication of records
shall be sent in writing to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
■ 13. Revise § 20.26(b), to read as
follows:
§ 20.26
Indexes of certain records.
*
[Amended]
§ 20.30 Food and Drug Administration
Division of Freedom of Information.
*
3. The authority citation for 21 CFR
part 10 continues to read as follows:
■
index is available by writing to the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857, or
by visiting the Division of Freedom of
Information Public Reading Room,
located in rm. 1050, at the same address.
■ 14. Revise § 20.30 to read as follows:
§ 20.3 Certification and authentication of
Food and Drug Administration records.
■
§ 10.85
12. Revise § 20.3(b) to read as follows:
31469
*
*
*
*
(b) Each such index will be made
available through the Internet at https://
www.fda.gov. A printed copy of each
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[Amended]
17. In § 20.44(e), remove ‘‘Freedom of
Information Staff’’ and in its place add
‘‘Division of Freedom of Information’’.
■ 18. In § 20.107(a), revise the second
sentence to read as follows:
§ 20.107 Food and Drug Administration
manuals.
(a) * * * An index of all such
manuals is available by writing to the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857; or
by visiting the Division of Freedom of
Information Public Reading Room,
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Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Rules and Regulations
located in rm. 1050, at the same address.
* * *
*
*
*
*
*
■ 19. In § 20.108, remove ‘‘Freedom of
Information Public Room’’ everywhere it
appears and in its place add ‘‘Division
of Freedom of Information Public
Reading Room’’.
■ 20. In § 20.120, revise paragraph (a);
paragraph (b) introductory text; and
paragraph (b)(4) to read as follows:
§ 20.120 Records available in Food and
Drug Administration Public Reading
Rooms.
its place add ‘‘Division of Freedom of
Information Public Reading Room’’.
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
§ 814.45
26. The authority citation for 21 CFR
part 314 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 356a, 356b, 356c, 371, 374,
379e.
27. In § 314.53(e), revise the last two
sentences to read as follows:
■
§ 314.53
(a) The Food and Drug Administration
operates two public reading rooms. The
Division of Freedom of Information
Public Reading Room is located in rm.
1050, 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857; the
telephone number is 301–796–3900.
The Division of Dockets Management
Public Reading Room is located in rm.
1061, 5630 Fishers Lane, Rockville, MD
20852; the telephone number is 301–
827–6860. Both public reading rooms
are open from 9 a.m. to 4 p.m., Monday
through Friday, excluding legal public
holidays.
(b) The following records are available
at the Division of Freedom of
Information Public Reading Room:
*
*
*
*
*
(4) Indexes of records maintained in
the Division of Freedom of Information
Public Reading Room; and
*
*
*
*
*
*
PART 21—PROTECTION OF PRIVACY
Submission of patent information.
■
21. The authority citation for 21 CFR
part 21 continues to read as follows:
■
Authority: 21 U.S.C. 371; 5 U.S.C. 552,
552a.
§ 21.32
[Amended]
*
*
*
*
(e) * * * Patent information received
by the Agency between monthly
publication of supplements to the list
will be placed on public display in
FDA’s Division of Freedom of
Information. A request for copies of the
file shall be sent in writing to the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
*
*
*
*
*
§ 21.41
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 360, 371.
§ 350.60
[Amended]
29. In § 350.60, in the last sentence,
remove ‘‘FOI Staff (HFI–35), 5600
Fishers Lane, rm. 12A–16,’’ and in its
place add ‘‘Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg.,’’.
30. The authority citation for part 516
continues to read as follows:
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
§ 516.157
[Amended]
24. In § 21.41, remove ‘‘Freedom of
Information Staff’’ everywhere it appears
and in its place add ‘‘Division of
Freedom of Information (ELEM–1029)’’;
and remove ‘‘(HFI–30)’’ everywhere it
appears.
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§ 21.43
[Amended]
25. In § 21.43(a)(2), remove ‘‘Freedom
of Information Staff public room’’ and in
■
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[Amended]
31. In § 516.157(a), remove ‘‘Freedom
of Information Staff or by visiting the
FDA Freedom of Information Public
Reading Room’’ and in its place add
‘‘Division of Freedom of Information or
by visiting FDA’s Division of Freedom
of Information Public Reading Room’’.
■
■
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 545
Taliban (Afghanistan) Sanctions
Regulations
Office of Foreign Assets
Control, Treasury
ACTION: Final rule.
SUMMARY:
■
[Amended]
BILLING CODE 4160–01–P
28. The authority citation for 21 CFR
part 350 continues to read as follows:
■
§ 21.40
23. In § 21.40(b), remove ‘‘(HFI–30),
Food and Drug Administration, 5600
Fishers Lane,’’ and in its place add
‘‘(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg.,’’.
[FR Doc. 2011–13488 Filed 5–31–11; 8:45 am]
AGENCY:
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
■
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
PART 350—ANTIPERSPIRANT DRUG
PRODUCTS FOR OVER-THECOUNTER HUMAN USE
22. In 21.32(b)(2), remove ‘‘(HFI–30)’’
and in its place add ‘‘(ELEM–1029)’’.
■
[Amended]
33. In § 814.45(d)(2), remove
‘‘Freedom of Information Staff (HFI–35),
Food and Drug Administration, 5600
Fishers Lane,’’ and in its place add
‘‘Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg.,’’.
■
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
32. The authority citation for 21 CFR
part 814 continues to read as follows:
■
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The Department of the
Treasury’s Office of Foreign Assets
Control (‘‘OFAC’’) is removing from the
Code of Federal Regulations the Taliban
(Afghanistan) Sanctions Regulations, 31
CFR part 545, as a result of the
termination of the national emergency
and revocation of the Executive order on
which part 545 was based. Sanctions
against the Taliban pursuant to
Executive Order 13224 and the Global
Terrorism Sanctions Regulations, 31
CFR part 594, remain in place.
DATES: Effective Date: June 1, 2011.
FOR FURTHER INFORMATION CONTACT:
Assistant Director for Sanctions
Compliance & Evaluation, tel.: 202/622–
2490, Assistant Director for Licensing,
tel.: 202/622–2480, Assistant Director
for Policy, tel.: 202/622–4855, Office of
Foreign Assets Control, or Chief Counsel
(Foreign Assets Control), tel.: 202/622–
2410, Office of the General Counsel,
Department of the Treasury (not toll free
numbers).
SUPPLEMENTARY INFORMATION:
Electronic and Facsimile Availability
This document and additional
information concerning OFAC are
available from OFAC’s Web site
(https://www.treasury.gov/ofac). Certain
general information pertaining to
OFAC’s sanctions programs also is
available via facsimile through a 24-
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]]>Agencies
[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Rules and Regulations]
[Pages 31468-31470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13488]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 5, 10, 14, 19, 20, 21, 314, 350, 516, and 814
[Docket No. FDA-2011-N-0318]
Division of Freedom of Information; Change of Office Name,
Address, Telephone Number, and Fax Number; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
Agency's regulations to reflect changes to the Division of Freedom of
Information's office name, address, telephone number, and fax number
and the Division of Freedom of Information Public Reading room's fax
and room number. This action is editorial in nature and is intended to
improve the accuracy of the Agency's regulations.
DATES: This rule is effective June 1, 2011.
FOR FURTHER INFORMATION CONTACT: Fred Sadler, Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857, 301-796-8975.
SUPPLEMENTARY INFORMATION: FDA is making technical amendments in the
Agency's regulations under 21 CFR parts 5, 10, 14, 19, 20, 21, 314,
350, 516, and 814 as a result of a recent office move. The former
address, telephone number, and fax number was: rm. 6-30, Parklawn
Bldg., 5600 Fishers Lane, Rockville, MD 20857, telephone: 301-827-6567,
FAX: 301-443-1726. The new address is: Division of Freedom of
Information (ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857, telephone: 301-796-3900, FAX: 301-796-9267. The Division of
Freedom of Information Public Reading Room number is 1050.
Publication of this document constitutes final action of these
changes under the Administrative Procedures Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because these
amendments are merely correcting nonsubstantive errors.
List of Subjects
21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
21 CFR Part 19
Conflict of interests.
21 CFR Part 20
Confidential business information, Courts, Freedom of Information,
Government employees.
[[Page 31469]]
21 CFR Part 21
Privacy.
21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
21 CFR Part 350
Labeling, Over-the-counter drugs.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
5, 10, 14, 19, 20, 21, 314, 350, 516, and 814 are amended as follows:
PART 5--ORGANIZATION
0
1. The authority citation for 21 CFR part 5 continues to read as
follows:
Authority: 5 U.S.C. 552; 21 U.S.C. 301-397.
0
2. Revise Sec. 5.1110(b) to read as follows:
Sec. 5.1110 FDA public information offices.
* * * * *
(b) Division of Freedom of Information. The Division of Freedom of
Information Public Reading Room is located in rm. 1050, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857; Telephone: 301-796-3900.
* * * * *
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
0
3. The authority citation for 21 CFR part 10 continues to read as
follows:
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
Sec. 10.85 [Amended]
0
4. In Sec. 10.85(d)(4), remove ``Freedom of Information Staff (HFI-
35)'' and in its place add ``Division of Freedom of Information (ELEM-
1029)''.
Sec. 10.90 [Amended]
0
5. In Sec. 10.90(d), remove ``Freedom of Information Staff (HFI-35),''
and in its place add ``Division of Freedom of Information (ELEM-
1029)''.
Sec. 10.95 [Amended]
0
6. In Sec. 10.95, remove ``Freedom of Information Staff'' and
``Freedom of Information Staff (HFI-35)'' everywhere they appear and in
their places add ``Division of Freedom of Information (ELEM-1029)''.
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
0
7. The authority citation for 21 CFR part 14 continues to read as
follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.
Sec. 14.65 [Amended]
0
8. In Sec. 14.65(c), remove ``Freedom of Information Staff (HFI-35)''
and in its place add ``Division of Freedom of Information (ELEM-
1029)''.
PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
0
9. The authority citation for 21 CFR part 19 continues to read as
follows:
Authority: 21 U.S.C. 371.
Sec. 19.10 [Amended]
0
10. In Sec. 19.10(d) introductory text, remove ``Freedom of
Information Staff'' and in its place add ``Division of Freedom of
Information''.
PART 20--PUBLIC INFORMATION
0
11. The authority citation for 21 CFR part 20 continues to read as
follows:
Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
0
12. Revise Sec. 20.3(b) to read as follows:
Sec. 20.3 Certification and authentication of Food and Drug
Administration records.
* * * * *
(b) A request for certified copies of records or for authentication
of records shall be sent in writing to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
0
13. Revise Sec. 20.26(b), to read as follows:
Sec. 20.26 Indexes of certain records.
* * * * *
(b) Each such index will be made available through the Internet at
https://www.fda.gov. A printed copy of each index is available by
writing to the Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857, or by visiting the Division of Freedom of Information Public
Reading Room, located in rm. 1050, at the same address.
0
14. Revise Sec. 20.30 to read as follows:
Sec. 20.30 Food and Drug Administration Division of Freedom of
Information.
(a) The office responsible for Agency compliance with the Freedom
of Information Act and this part is the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
(b) All requests for Agency records shall be sent in writing to
this office.
0
15. In Sec. 20.40, revise paragraph (a); and in paragraph (c), remove
``Freedom of Information Staff'' and in its place add ``Division of
Freedom of Information'' to read as follows:
Sec. 20.40 Filing a request for records.
(a) All requests for Food and Drug Administration records shall be
made in writing by mailing or delivering the request to the Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857; or by faxing it to
301-796-9267. All requests must contain the postal address and
telephone number of the requester and the name of the person
responsible for payment of any fees that may be charged.
* * * * *
Sec. 20.41 [Amended]
0
16. In Sec. 20.41 paragraph (a), paragraph (b) introductory text, and
paragraph (c), remove ``Freedom of Information Staff'' and in its place
add ``Division of Freedom of Information''.
Sec. 20.44 [Amended]
0
17. In Sec. 20.44(e), remove ``Freedom of Information Staff'' and in
its place add ``Division of Freedom of Information''.
0
18. In Sec. 20.107(a), revise the second sentence to read as follows:
Sec. 20.107 Food and Drug Administration manuals.
(a) * * * An index of all such manuals is available by writing to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857;
or by visiting the Division of Freedom of Information Public Reading
Room,
[[Page 31470]]
located in rm. 1050, at the same address. * * *
* * * * *
0
19. In Sec. 20.108, remove ``Freedom of Information Public Room''
everywhere it appears and in its place add ``Division of Freedom of
Information Public Reading Room''.
0
20. In Sec. 20.120, revise paragraph (a); paragraph (b) introductory
text; and paragraph (b)(4) to read as follows:
Sec. 20.120 Records available in Food and Drug Administration Public
Reading Rooms.
(a) The Food and Drug Administration operates two public reading
rooms. The Division of Freedom of Information Public Reading Room is
located in rm. 1050, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857; the telephone number is 301-796-3900. The Division of Dockets
Management Public Reading Room is located in rm. 1061, 5630 Fishers
Lane, Rockville, MD 20852; the telephone number is 301-827-6860. Both
public reading rooms are open from 9 a.m. to 4 p.m., Monday through
Friday, excluding legal public holidays.
(b) The following records are available at the Division of Freedom
of Information Public Reading Room:
* * * * *
(4) Indexes of records maintained in the Division of Freedom of
Information Public Reading Room; and
* * * * *
PART 21--PROTECTION OF PRIVACY
0
21. The authority citation for 21 CFR part 21 continues to read as
follows:
Authority: 21 U.S.C. 371; 5 U.S.C. 552, 552a.
Sec. 21.32 [Amended]
0
22. In 21.32(b)(2), remove ``(HFI-30)'' and in its place add ``(ELEM-
1029)''.
Sec. 21.40 [Amended]
0
23. In Sec. 21.40(b), remove ``(HFI-30), Food and Drug Administration,
5600 Fishers Lane,'' and in its place add ``(ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg.,''.
Sec. 21.41 [Amended]
0
24. In Sec. 21.41, remove ``Freedom of Information Staff'' everywhere
it appears and in its place add ``Division of Freedom of Information
(ELEM-1029)''; and remove ``(HFI-30)'' everywhere it appears.
Sec. 21.43 [Amended]
0
25. In Sec. 21.43(a)(2), remove ``Freedom of Information Staff public
room'' and in its place add ``Division of Freedom of Information Public
Reading Room''.
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
0
26. The authority citation for 21 CFR part 314 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 371, 374, 379e.
0
27. In Sec. 314.53(e), revise the last two sentences to read as
follows:
Sec. 314.53 Submission of patent information.
* * * * *
(e) * * * Patent information received by the Agency between monthly
publication of supplements to the list will be placed on public display
in FDA's Division of Freedom of Information. A request for copies of
the file shall be sent in writing to the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
* * * * *
PART 350--ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE
0
28. The authority citation for 21 CFR part 350 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Sec. 350.60 [Amended]
0
29. In Sec. 350.60, in the last sentence, remove ``FOI Staff (HFI-35),
5600 Fishers Lane, rm. 12A-16,'' and in its place add ``Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg.,''.
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
30. The authority citation for part 516 continues to read as follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
Sec. 516.157 [Amended]
0
31. In Sec. 516.157(a), remove ``Freedom of Information Staff or by
visiting the FDA Freedom of Information Public Reading Room'' and in
its place add ``Division of Freedom of Information or by visiting FDA's
Division of Freedom of Information Public Reading Room''.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
32. 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.
Sec. 814.45 [Amended]
0
33. In Sec. 814.45(d)(2), remove ``Freedom of Information Staff (HFI-
35), Food and Drug Administration, 5600 Fishers Lane,'' and in its
place add ``Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg.,''.
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13488 Filed 5-31-11; 8:45 am]
BILLING CODE 4160-01-P
