Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, 60476 [2014-23842]

Download as PDF 60476 Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section/FDA Form Number of responses per respondent Total annual responses Average burden per response Total hours 316.10, 316.12, and 316.14 ................................................. 316.20, 316.21, and 316.26 ................................................. Form FDA 3671 ................................................................... 316.22 .................................................................................. 316.27 .................................................................................. 316.30 .................................................................................. 316.36 .................................................................................. 2 225 50 65 43 450 2 1 2 3 1 1 1 3 2 450 150 65 43 450 6 100 150 45 2 5 3 15 200 67,500 6,750 130 215 1,350 90 Total .............................................................................. ........................ ........................ ........................ ........................ 76,235 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 1, 2014. Leslie Kux, Assistant Commissioner for Policy. collection and has assigned OMB control number 0910–0693. 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. [FR Doc. 2014–23846 Filed 10–6–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 1, 2014. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration [FR Doc. 2014–23842 Filed 10–6–14; 8:45 am] [Docket No. FDA–2014–N–0222] BILLING CODE 4164–01–P Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products’’ 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 16, 2014, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products’’ 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:15 Oct 06, 2014 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0432] Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.’’ This guidance is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the neoadjuvant (preoperative) setting using pathological complete response (pCR) as a surrogate endpoint that could support approval under the accelerated approval regulations. Despite advances in systemic therapy of early-stage breast cancer over the past few decades, there remains a significant unmet medical need for certain high-risk or poor prognosis populations of early-stage SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 breast cancer patients. This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012. 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 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– 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 guidance document. Submit electronic comments on the 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: Tatiana Prowell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2112, Silver Spring, MD 20993–0002, 301– 796–2330. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.’’ Under the accelerated approval regulations (21 CFR part 314, subpart H, and 21 CFR part 601, subpart E), FDA may grant marketing approval for a new drug on the basis of adequate and well-controlled trials establishing E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Page 60476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0222]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on User Fee 
Waivers, Reductions, and Refunds for Drug and Biological Products

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 on User Fee 
Waivers, Reductions, and Refunds for Drug and Biological Products'' 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 16, 2014, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
User Fee Waivers, Reductions, and Refunds for Drug and Biological 
Products'' 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 0910-0693. 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: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23842 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P