80 FR 44357 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 143 (July 27, 2015)

Page Range		44357-44357
FR Document		2015-18295

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 143 (Monday, July 27, 2015)

[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Page 44357]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Generic Clearance for the Collection 
of Qualitative Data on Tobacco Products and Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Generic Clearance for the 
Collection of Qualitative Data on Tobacco Products and Communications'' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: On December 10, 2014, the Agency submitted a 
proposed collection of information entitled, ``Generic Clearance for 
the Collection of Qualitative Data on Tobacco Products and 
Communications'' to OMB for review and clearance under 44 U.S.C. 3507. 
An Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0796. The approval 
expires on June 30, 2018. A copy of the supporting statement for this 
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18295 Filed 7-24-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices 44357

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden Total burden
Type of respondents Form name responses per
respondents per response hours
respondent (in hours)

International Panel Physi- TB Indicators Excel Spread- 353 1 7.5 2,648
cians (All sites). sheet.

TOTAL .......................... .............................................. .............................. ................................ .............................. 2,648

Leroy A. Richardson, 0910–0796. The approval expires on Floor, Silver Spring, MD 20993, or to
Chief, Information Collection Review Office, June 30, 2018. A copy of the supporting the Office of Communication, Outreach
Office of Scientific Integrity, Office of the statement for this information collection and Development, Center for Biologics
Associate Director for Science, Office of the is available on the Internet at http:// Evaluation and Research (CBER), Food
Director, Centers for Disease Control and www.reginfo.gov/public/do/PRAMain. and Drug Administration, 10903 New
Prevention.
Dated: July 22, 2015. Hampshire Ave., Bldg. 71, Rm. 3128,
[FR Doc. 2015–18301 Filed 7–24–15; 8:45 am]
Leslie Kux, Silver Spring, MD 20993–0002. Send
BILLING CODE 4163–18–P one self-addressed adhesive label to
Associate Commissioner for Policy.
assist that office in processing your
[FR Doc. 2015–18295 Filed 7–24–15; 8:45 am]
requests. The guidance may also be
DEPARTMENT OF HEALTH AND BILLING CODE 4164–01–P
obtained by mail by calling CBER at
HUMAN SERVICES
1–800–835–4709 or 240–402–7800. See
Food and Drug Administration DEPARTMENT OF HEALTH AND the SUPPLEMENTARY INFORMATION section
HUMAN SERVICES for electronic access to the guidance
[Docket No. FDA–2014–N–0987] document.
Food and Drug Administration Submit electronic comments on the
Agency Information Collection guidance to http://www.regulations.gov.
Activities; Announcement of Office of [Docket No. FDA–2014–D–0103] Submit written comments to the
Management and Budget Approval;
Division of Dockets Management (HFA–
Generic Clearance for the Collection of Analytical Procedures and Methods
305), Food and Drug Administration,
Qualitative Data on Tobacco Products Validation for Drugs and Biologics;
5630 Fishers Lane, Room 1061,
and Communications Guidance for Industry; Availability
Rockville, MD 20852.
AGENCY: Food and Drug Administration, AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
HHS. HHS. Lucinda Buhse, Center for Drug
ACTION: Notice. ACTION: Notice. Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY: The Food and Drug SUMMARY: The Food and Drug Hampshire Ave., Bldg. 22, Rm. 2130,
Administration (FDA) is announcing Administration (FDA) is announcing the Silver Spring, MD 20993–0002, 240–
that a collection of information entitled, availability of a guidance for industry 402–4595, or Stephen Ripley, Center for
‘‘Generic Clearance for the Collection of entitled ‘‘Analytical Procedures and Biologics Evaluation and Research,
Qualitative Data on Tobacco Products Methods Validation for Drugs and Food and Drug Administration, 10903
and Communications’’ has been Biologics.’’ This guidance supersedes New Hampshire Ave., Bldg. 71, Rm.
approved by the Office of Management the draft of the same name that 7301, Silver Spring, MD 20993–0002,
and Budget (OMB) under the Paperwork published on February 19, 2014, and 240–402–7911.
Reduction Act of 1995. replaces the 2000 draft guidance for
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT: FDA industry on ‘‘Analytical Procedures and
PRA Staff, Office of Operations, Food Methods Validation’’ and the 1987 FDA I. Background
and Drug Administration, 8455 guidance for industry on ‘‘Submitting FDA is announcing the availability of
Colesville Rd., COLE–14526, Silver Samples and Analytical Data for a guidance for industry entitled
Spring, MD 20993–0002, PRAStaff@ Methods Validation.’’ This guidance ‘‘Analytical Procedures and Methods
fda.hhs.gov. discusses how to submit analytical Validation for Drugs and Biologics.’’
SUPPLEMENTARY INFORMATION: On
procedures and methods validation data This guidance supersedes the draft of
December 10, 2014, the Agency to support the documentation of the the same name that published on
submitted a proposed collection of identity, strength, quality, purity, and February 19, 2014, and replaces the
information entitled, ‘‘Generic potency of drug substances and drug 2000 draft guidance for industry on
Clearance for the Collection of products. ‘‘Analytical Procedures and Methods
Qualitative Data on Tobacco Products DATES: Submit either electronic or Validation’’ and the 1987 FDA guidance
and Communications’’ to OMB for written comments on Agency guidances for industry on ‘‘Submitting Samples
review and clearance under 44 U.S.C. at any time. and Analytical Data for Methods
tkelley on DSK3SPTVN1PROD with NOTICES

3507. An Agency may not conduct or ADDRESSES: Submit written requests for Validation.’’ It discusses how to submit
sponsor, and a person is not required to single copies of this guidance to the analytical procedures and methods
respond to, a collection of information Office of Communications, Division of validation data to support the
unless it displays a currently valid OMB Drug Information, Center for Drug documentation of the identity, strength,
control number. OMB has now Evaluation and Research, Food and quality, purity, and potency of drug
approved the information collection and Drug Administration, 10001 New substances and drug products, and how
has assigned OMB control number Hampshire Ave., Hillandale Bldg., 4th to assemble information and present

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 44357

80 FR 44357 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 143 (July 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration