Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development, 66910 [2015-27741]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES 66910 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Martin Mendoza, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2306, Silver Spring, MD 20993– 0002, Martin.Mendoza@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to facilitate a unique opportunity for relevant stakeholders, including industry, academia, patients, and FDA, to discuss the importance of diversity in medical research and the incorporation VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 of participant diversity in the design, analysis, and regulation of medical interventions. Medical interventions may have different benefits and harms for subgroups within a population. If clinical trials do not include an adequate number of participants who are representative of people likely to use an approved intervention, then the average results of clinical trials might not be replicated in practice. Even if clinical trials include representative participants, important subgroup differences might not be detectable if their representation is not adequate. For these reasons, regulators might use a combination of information from clinical trials and other data sources to address questions about heterogeneity across large and diverse populations. The use of data from patients in their usual care setting (‘‘real-world’’ data) may be particularly valuable for understanding this heterogeneity. Agenda: The agenda is located at: https://www.jhsph.edu/research/centersand-institutes/center-of-excellence-inregulatory-science-and-innovation/ news-and-events/clinical-trialsassessing-safety-and-efficacy-fordiverse-population.html. (FDA has verified the Web site addresses throughout this notice, but FDA is not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register). Registration: There is no registration fee to attend this meeting. Seats are limited, and registration will be on a first-come, first-served basis. To register, please complete registration online at https://www.surveymonkey.com/r/ ClinicalTrialsWorkshop120215. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations due to a disability, please contact Jill Zung at Jill.Zung@fda.hhs.gov at least 7 days in advance. Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1167] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development 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 Controlled Correspondence Related to Generic Drug Development’’ 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 July 9, 2015, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Controlled Correspondence Related to Generic Drug Development’’ 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 0910–0797. The approval expires on September 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. SUPPLEMENTARY INFORMATION: Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–27741 Filed 10–29–15; 8:45 am] BILLING CODE 4164–01–P [FR Doc. 2015–27728 Filed 10–29–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Page 66910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1167]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Controlled 
Correspondence Related to Generic Drug Development

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 
Controlled Correspondence Related to Generic Drug Development'' 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 9, 2015, the Agency submitted a 
proposed collection of information entitled ``Guidance for Industry on 
Controlled Correspondence Related to Generic Drug Development'' 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 0910-0797. The approval expires on 
September 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: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27741 Filed 10-29-15; 8:45 am]
BILLING CODE 4164-01-P
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