80_FR_67120 80 FR 66910 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development

80 FR 66910 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Controlled Correspondence Related to Generic Drug Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 210 (October 30, 2015)

Page Range66910-66910
FR Document2015-27741

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.

Federal Register, Volume 80 Issue 210 (Friday, October 30, 2015) 
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Page 66910]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

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 http://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

66910 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices comments will be placed in the docket of participant diversity in the design, DEPARTMENT OF HEALTH AND and, except for those submitted as analysis, and regulation of medical HUMAN SERVICES ‘‘Confidential Submissions,’’ publicly interventions. Medical interventions viewable at http://www.regulations.gov may have different benefits and harms Food and Drug Administration or at the Division of Dockets for subgroups within a population. If Management between 9 a.m. and 4 p.m., clinical trials do not include an [Docket No. FDA–2014–D–1167] Monday through Friday. adequate number of participants who • Confidential Submissions—To are representative of people likely to use Agency Information Collection submit a comment with confidential an approved intervention, then the Activities; Announcement of Office of information that you do not wish to be average results of clinical trials might Management and Budget Approval; made publicly available, submit your Guidance for Industry on Controlled not be replicated in practice. Even if comments only as a written/paper Correspondence Related to Generic clinical trials include representative submission. You should submit two Drug Development participants, important subgroup copies total. One copy will include the information you claim to be confidential differences might not be detectable if their representation is not adequate. For AGENCY: Food and Drug Administration, with a heading or cover note that states HHS. ‘‘THIS DOCUMENT CONTAINS these reasons, regulators might use a CONFIDENTIAL INFORMATION’’. The combination of information from ACTION: Notice. Agency will review this copy, including clinical trials and other data sources to the claimed confidential information, in address questions about heterogeneity SUMMARY: The Food and Drug its consideration of comments. The across large and diverse populations. Administration (FDA) is announcing second copy, which will have the The use of data from patients in their that a collection of information entitled claimed confidential information usual care setting (‘‘real-world’’ data) ‘‘Guidance for Industry on Controlled redacted/blacked out, will be available may be particularly valuable for Correspondence Related to Generic Drug for public viewing and posted on understanding this heterogeneity. Development’’ has been approved by the http://www.regulations.gov. Submit Agenda: The agenda is located at: Office of Management and Budget both copies to the Division of Dockets http://www.jhsph.edu/research/centers- (OMB) under the Paperwork Reduction Management. If you do not wish your and-institutes/center-of-excellence-in- Act of 1995. name and contact information to be regulatory-science-and-innovation/ made publicly available, you can FOR FURTHER INFORMATION CONTACT: FDA news-and-events/clinical-trials- PRA Staff, Office of Operations, Food provide this information on the cover assessing-safety-and-efficacy-for- and Drug Administration, 8455 sheet and not in the body of your diverse-population.html. (FDA has Colesville Rd., COLE–14526, Silver comments and you must identify this information as ‘‘confidential.’’ Any verified the Web site addresses Spring, MD 20993–0002, PRAStaff@ information marked as ‘‘confidential’’ throughout this notice, but FDA is not fda.hhs.gov. will not be disclosed except in responsible for subsequent changes to accordance with 21 CFR 10.20 and other the Web sites after this document SUPPLEMENTARY INFORMATION: On July 9, applicable disclosure law. For more publishes in the Federal Register). 2015, the Agency submitted a proposed information about FDA’s posting of Registration: There is no registration collection of information entitled comments to public dockets, see 80 FR fee to attend this meeting. Seats are ‘‘Guidance for Industry on Controlled 56469, September 18, 2015, or access limited, and registration will be on a Correspondence Related to Generic Drug the information at: http://www.fda.gov/ first-come, first-served basis. To register, Development’’ to OMB for review and regulatoryinformation/dockets/ please complete registration online at clearance under 44 U.S.C. 3507. An default.htm. http://www.surveymonkey.com/r/ Agency may not conduct or sponsor, Docket: For access to the docket to ClinicalTrialsWorkshop120215. (FDA and a person is not required to respond read background documents or the has verified the Web address, but FDA to, a collection of information unless it electronic and written/paper comments is not responsible for subsequent displays a currently valid OMB control received, go to http:// number. OMB has now approved the changes to the Web site after this www.regulations.gov and insert the information collection and has assigned document publishes in the Federal docket number, found in brackets in the OMB control number 0910–0797. The heading of this document, into the Register.) approval expires on September 30, ‘‘Search’’ box and follow the prompts Accommodations: Attendees are 2018. A copy of the supporting and/or go to the Division of Dockets responsible for their own hotel statement for this information collection Management, 5630 Fishers Lane, Rm. accommodations. If you need special is available on the Internet at http:// 1061, Rockville, MD 20852. accommodations due to a disability, www.reginfo.gov/public/do/PRAMain. FOR FURTHER INFORMATION CONTACT: please contact Jill Zung at Martin Mendoza, Office of Minority Jill.Zung@fda.hhs.gov at least 7 days in Dated: October 26, 2015. Health, Food and Drug Administration, advance. Leslie Kux, 10903 New Hampshire Ave., Bldg. 32, Dated: October 26, 2015. Associate Commissioner for Policy. Rm. 2306, Silver Spring, MD 20993– [FR Doc. 2015–27741 Filed 10–29–15; 8:45 am] Leslie Kux, 0002, Martin.Mendoza@fda.hhs.gov. BILLING CODE 4164–01–P Associate Commissioner for Policy. tkelley on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: The [FR Doc. 2015–27728 Filed 10–29–15; 8:45 am] purpose of this public workshop is to facilitate a unique opportunity for BILLING CODE 4164–01–P 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\30OCN1.SGM 30OCN1


Document Created: 2015-12-14 15:29:56
Document Modified: 2015-12-14 15:29:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 66910 
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