Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile, 56588 [2014-22452]

Download as PDF 56588 Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Activity Total annual responses Average burden per response Focus groups .................................................... Customer comment cards/forms ...................... Small discussion groups ................................... Customer satisfaction surveys .......................... 725 1,200 725 6,450 1 1 1 1 725 1,200 725 6,450 Total ........................................................... ........................ ........................ ........................ 1 There approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. [FR Doc. 2014–22461 Filed 9–19–14; 8:45 am] BILLING CODE 4164–01–P Dated: September 16, 2014. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2014–22452 Filed 9–19–14; 8:45 am] BILLING CODE 4164–01–P Food and Drug Administration [Docket No. FDA–2013–N–1164] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile’’ 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. On July 22, 2014, the Agency submitted a proposed collection of information entitled ‘‘Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile’’ 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 0910–0614. The SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:07 Sep 19, 2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Bioequivalence Recommendations for Estradiol Vaginal Cream; Draft Guidance for Industry; Availability AGENCY: SUMMARY: asabaliauskas on DSK5VPTVN1PROD with NOTICES ................................... (15 minutes) ............. ................................... (20 minutes) ............. 1,269 300 1,269 2,129 ........................................... 4,967 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 16, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: 1.75 0.25 1.75 0.33 Total hours Jkt 232001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ‘‘Draft Guidance on Estradiol.’’ The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for estradiol vaginal cream. This draft guidance is a revised version of a previously issued draft guidance of the same subject. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 21, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993. SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kris ´ Andre, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1615, Silver Spring, MD 20993, 240–402–7800. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of revised draft BE recommendations for estradiol vaginal cream. ANDA 086069 for Estrace Cream (estradiol vaginal cream, USP, 0.01%) was initially approved by FDA in January 1984. In August 2009, FDA issued a draft guidance for industry on BE recommendations for generic estradiol vaginal cream. FDA is now issuing a revised version of the draft BE recommendations for estradiol vaginal cream. This revised draft guidance changes the recommendation for an in E:\FR\FM\22SEN1.SGM 22SEN1

Agencies

[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Page 56588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1164]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Exceptions or Alternatives to 
Labeling Requirements for Products Held by the Strategic National 
Stockpile

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 ``Exceptions Or Alternatives to 
Labeling Requirements for Products Held by the Strategic National 
Stockpile'' 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 July 22, 2014, the Agency submitted a 
proposed collection of information entitled ``Exceptions Or 
Alternatives to Labeling Requirements for Products Held by the 
Strategic National Stockpile'' 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 0910-0614. 
The approval expires on August 31, 2017. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22452 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P