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, 44357 [2015-18295]

Download as PDF Federal Register / Vol. 80, No. 143 / Monday, July 27, 2015 / Notices 44357 ESTIMATED ANNUALIZED BURDEN HOURS Form name International Panel Physicians (All sites). TB Indicators Excel Spreadsheet. TOTAL .......................... 353 .............................................. .............................. Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–18301 Filed 7–24–15; 8:45 am] BILLING CODE 4163–18–P ................................ 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 https:// 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 Food and Drug Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES 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, ACTION: [Docket No. FDA–2014–D–0103] Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry; Availability AGENCY: ACTION: Notice. 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, PRAStaff@ fda.hhs.gov. 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 SUMMARY: tkelley on DSK3SPTVN1PROD with NOTICES Food and Drug Administration Food and Drug Administration, HHS. HHS. VerDate Sep<11>2014 18:58 Jul 24, 2015 Jkt 235001 Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Analytical Procedures and Methods Validation for Drugs and Biologics.’’ This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ‘‘Analytical Procedures and Methods Validation’’ and the 1987 FDA guidance for industry on ‘‘Submitting Samples and Analytical Data for Methods Validation.’’ This guidance discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Total burden hours 7.5 2,648 .............................. 2,648 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2014–N–0987] Average burden per response (in hours) Number of responses per respondent Number of respondents Type of respondents Floor, Silver Spring, MD 20993, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402–7800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lucinda Buhse, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2130, Silver Spring, MD 20993–0002, 240– 402–4595, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Analytical Procedures and Methods Validation for Drugs and Biologics.’’ This guidance supersedes the draft of the same name that published on February 19, 2014, and replaces the 2000 draft guidance for industry on ‘‘Analytical Procedures and Methods Validation’’ and the 1987 FDA guidance for industry on ‘‘Submitting Samples and Analytical Data for Methods Validation.’’ It discusses how to submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products, and how to assemble information and present E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Page 44357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, PRAStaff@fda.hhs.gov.

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 https://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
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