80 FR 8324 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range		8324-8325
FR Document		2015-03144

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015)

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8324-8325]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Title: Uniform Project Description (UPD) Program Narrative Format 
for Discretionary Grant Application Forms.
    OMB No.: 0970-0139.
    Description: The proposed information collection would renew the 
Administration for Children and Families (ACF) Uniform Project 
Description (UPD). The UPD provides a uniform grant application format 
for applicants to submit project information in response to ACF 
discretionary funding opportunity announcements. ACF uses this 
information, along with other OMB-approved information collections 
(Standard Forms), to evaluate and rank applications. Use of the UPD 
helps to protect the integrity of ACF's award selection process. All 
ACF discretionary grant programs are required to use this application 
format. An ACF application consists of general information and 
instructions; the Standard Form 424 series, which requests basic 
information, budget information, and assurances; the Project 
Description that requests the applicant to describe how program 
objectives will be achieved; a rationale for the project's budgeted 
costs; and other assurances and certifications. Guidance for the 
content of information requested in the Project Description is based in 
OMB Circular 45 CFR 75.203.
    Respondents: Applicants to ACF Discretionary Funding Opportunity 
Announcements.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ACF Uniform Project Description.............           4,850                1               60          291,000
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 291,000.
    In compliance with the requirements of Section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Planning, Research and Evaluation, 370 L'Enfant Promenade SW., 
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email 
address: [email protected]. All requests should be identified 
by the title of the information collection.
    ACF specifically requests comments on: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
the functions of the agency, including whether the information shall 
have practical utility; (b) the accuracy of the agency's estimate of 
the burden of the proposed collection of information; (c) the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden information to be collected; and (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use

[[Page 8325]]

of automated collection techniques or other forms of information 
technology. Consideration will be given to comments and suggestions 
submitted within 60 days of this publication.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-03144 Filed 2-13-15; 8:45 am]
BILLING CODE 4184-01-P

Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8325

of automated collection techniques or I. Background III. Comments
other forms of information technology. Interested persons may submit either
Consideration will be given to FDA is announcing the availability of
a guidance for industry entitled electronic comments regarding this
comments and suggestions submitted document to http://www.regulations.gov
within 60 days of this publication. ‘‘Complicated Urinary Tract Infections:
Developing Drugs for Treatment.’’ The or written comments to the Division of
Robert Sargis, purpose of this guidance is to assist Dockets Management (see ADDRESSES). It
Reports Clearance Officer. sponsors in the development of drugs is only necessary to send one set of
[FR Doc. 2015–03144 Filed 2–13–15; 8:45 am] for the treatment of cUTIs. comments. Identify comments with the
BILLING CODE 4184–01–P
docket number found in brackets in the
This guidance includes heading of this document. Received
recommendations for an efficacy comments may be seen in the Division
DEPARTMENT OF HEALTH AND endpoint and noninferiority trial design. of Dockets Management between 9 a.m.
HUMAN SERVICES The efficacy endpoint, based on and 4 p.m., Monday through Friday, and
resolution of clinical symptoms and will be posted to the docket at http://
Food and Drug Administration eradication of bacteria from the urinary www.regulations.gov.
tract, was derived from previously
[Docket No. FDA–2012–D–0148] IV. Electronic Access
conducted clinical trials for the
Complicated Urinary Tract Infections: treatment of cUTI. The guidance Persons with access to the Internet
Developing Drugs for Treatment; provides a scientific justification for a may obtain the document at either
Guidance for Industry; Availability noninferiority margin based on http://www.fda.gov/Drugs/Guidance
historical observational data compared ComplianceRegulatoryInformation/
AGENCY: Food and Drug Administration, to the results of previously conducted Guidances/default.htm or http://
HHS. clinical trials. After careful www.regulations.gov.
ACTION: Notice. consideration of comments received in Dated: February 10, 2015.
response to the revised draft guidance Leslie Kux,
SUMMARY: The Food and Drug
issued on February 24, 2012, important
Administration (FDA) is announcing the Associate Commissioner for Policy.
clarifications about trial populations
availability of a guidance for industry [FR Doc. 2015–03100 Filed 2–13–15; 8:45 am]
and endpoints for cUTI were included
entitled ‘‘Complicated Urinary Tract BILLING CODE 4164–01–P
in this guidance. In addition, this
Infections: Developing Drugs for
guidance reflects recent developments
Treatment.’’ The purpose of this
in scientific information that pertain to
guidance is to assist sponsors in the DEPARTMENT OF HEALTH AND
drugs being developed for the treatment
clinical development of drugs for the HUMAN SERVICES
of cUTI.
treatment of complicated urinary tract
infections (cUTIs). This guidance Issuance of this guidance fulfills a Food and Drug Administration
finalizes the revised draft guidance of portion of the requirements of title VIII, [Docket No. FDA–2015–N–0001]
the same name issued on February 24, section 804, of the Food and Drug
2012. Administration Safety and Innovation Society of Clinical Research
DATES: Submit either electronic or Act (Pub. L. 112–144), which requires Associates—Food and Drug
written comments on Agency guidances FDA to review and, as appropriate, Administration; ‘‘Food and Drug
at any time. revise not fewer than three guidance Administration Clinical Trial
documents per year for the conduct of Requirements, Regulations,
ADDRESSES: Submit written requests for
clinical trials with respect to Compliance and Good Clinical
single copies of this guidance to the
antibacterial and antifungal drugs. Practice’’
Division of Drug Information, Center for
Drug Evaluation and Research, Food This guidance is being issued
AGENCY: Food and Drug Administration,
and Drug Administration, 10001 New consistent with FDA’s good guidance
HHS.
Hampshire Ave., Hillandale Bldg., 4th practices regulation (21 CFR 10.115).
The guidance represents the Agency’s ACTION: Notice of Public Workshop.
Floor, Silver Spring, MD 20993. Send
one self-addressed adhesive label to current thinking on this topic. It does SUMMARY: The Food and Drug
assist that office in processing your not create or confer any rights for or on Administration (FDA) is announcing the
requests. See the SUPPLEMENTARY any person and does not operate to bind following conference: Educational
INFORMATION section for electronic FDA or the public. An alternative Conference co-sponsored with the
access to the guidance document. approach may be used if such approach Society of Clinical Research Associates
Submit electronic comments on the satisfies the requirements of the (SOCRA). The public workshop FDA’s
guidance to http://www.regulations.gov. applicable statutes and regulations. clinical trial requirements is designed to
Submit written comments to the aid the Clinical Research Professional’s
II. The Paperwork Reduction Act of
Division of Dockets Management (HFA– understanding of the mission,
1995
305), Food and Drug Administration, responsibilities and authority of the
5630 Fishers Lane, Rm. 1061, Rockville, This guidance refers to previously FDA and to facilitate interaction with
MD 20852. approved collections of information that FDA representatives. The program will
FOR FURTHER INFORMATION CONTACT: are subject to review by the Office of focus on the relationships among the
tkelley on DSK3SPTVN1PROD with NOTICES

Joseph G. Toerner, Center for Drug Management and Budget (OMB) under FDA and clinical trial staff, investigators
Evaluation and Research, Food and the Paperwork Reduction Act of 1995 and institutional review boards (IRB).
Drug Administration, 10903 New (44 U.S.C. 3501–3520). The collections Individual FDA representatives will
Hampshire Ave., Bldg. 22, Rm. 6244, of information in 21 CFR parts 312 and discuss the informed consent process
Silver Spring, MD 20993–0002, 301– 314 have been approved under OMB and informed consent documents;
796–1300. control numbers 0910–0014 and 0910– regulations relating to drugs, devices
SUPPLEMENTARY INFORMATION: 0001, respectively. and biologics, as well as inspections of

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Document Created: 2015-12-18 13:19:30
Document Modified: 2015-12-18 13:19:30

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 8324

80 FR 8324 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 31 (February 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families