Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys, 42800 [2014-17292]

Download as PDF 42800 Federal Register / Vol. 79, No. 141 / Wednesday, July 23, 2014 / Notices Dated: July 18, 2014. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2014–17294 Filed 7–22–14; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2007–D–0369] DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability Food and Drug Administration AGENCY: Food and Drug Administration, HHS. Notice. [Docket No. FDA–2013–N–1496] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Food and Drug Administration Rapid Response Surveys The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, 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. The BE recommendations identified in this notice were developed using the process described in that guidance. 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 these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by September 22, 2014. ADDRESSES: Submit written requests for single copies of the individual BE guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE recommendations to https:// 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 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Generic FDA Rapid Response Surveys’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On April 23, 2014, the Agency submitted a proposed collection of information entitled ‘‘Generic FDA Rapid Response Surveys’’ 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 0910–0500. The approval expires on July 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: July 18, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–17292 Filed 7–22–14; 8:45 am] BILLING CODE 4164–01–P VerDate Mar<15>2010 17:33 Jul 22, 2014 Jkt 232001 SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, rm. 1615, Silver Spring, MD 20993–0002, 240–402–7959. 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 https://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 productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received, and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on April 2, 2014 (79 FR 18561). This notice announces draft product-specific recommendations, either new or revised, that are posted on FDA’s Web site. II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing the availability of a new draft guidance for industry on product-specific BE recommendations for drug products containing the following active ingredients: TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS A ........ C ........ E:\FR\FM\23JYN1.SGM Alogliptin benzoate. Alogliptin benzoate; Metformin hydrochloride (HCl). Alogliptin benzoate; Pioglitazone HCl. Amoxicillin (multiple reference listed drugs). Atenolol; Chlorthalidone. Canagliflozin. Carbidopa. Carbinoxamine maleate. 23JYN1

Agencies

[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Page 42800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1496]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Generic Food and Drug Administration 
Rapid Response Surveys

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 FDA Rapid Response 
Surveys'' 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 April 23, 2014, the Agency submitted a 
proposed collection of information entitled ``Generic FDA Rapid 
Response Surveys'' 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 0910-0500. 
The approval expires on July 31, 2017. 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 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17292 Filed 7-22-14; 8:45 am]
BILLING CODE 4164-01-P

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