Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry-Pharmacogenomic Data Submissions, 43494 [2014-17481]

Download as PDF 43494 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Type of survey Number of respondents Annual frequency per response Average burden per response Total hours Mail, telephone, Web-based ............................................................................ 50,000 1 2 0.25 12,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Fifteen (15) minutes. Dated: July 18, 2014. Leslie Kux, Assistant Commissioner for Policy. Dated: July 21, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–17590 Filed 7–24–14; 8:45 am] [FR Doc. 2014–17481 Filed 7–24–14; 8:45 am] BILLING CODE 4164–01–P BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2014–N–1006] [Docket No. FDA–2007–N–0220] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry— Pharmacogenomic Data Submissions AGENCY: Food and Drug Administration, HHS. ACTION: AGENCY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry— Pharmacogenomic Data Submissions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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 May 9, 2014, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry— Pharmacogenomic Data Submissions’’ 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 0910–0557. 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. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:34 Jul 24, 2014 Food and Drug Administration, HHS. Notice. SUMMARY: emcdonald on DSK67QTVN1PROD with NOTICES Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Availability Jkt 232001 ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.’’ The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of the final version of the guidance on that topic. The draft guidance outlines Electronic Common Technical Document (eCTD) specification requirements for certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This draft guidance revises and replaces a previous draft guidance entitled ‘‘Providing Regulatory Submissions in SUMMARY: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’’ that was issued in January 2013 (2013 draft guidance on eCTD Specifications). When finalized, this revised draft guidance will supersede the guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications’’ that was issued in June 2008. 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 comment 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 September 23, 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, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit electronic comments on the draft guidance 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: Virginia Hussong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1161, Silver Spring, MD 20993, email: virginia.hussong@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Page 43494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0220]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry--
Pharmacogenomic Data Submissions

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 ``Guidance for Industry--
Pharmacogenomic Data Submissions'' 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 May 9, 2014, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry--
Pharmacogenomic Data Submissions'' 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 
0910-0557. 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 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17481 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P

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