Submission for OMB Review; Comment Request, 64005 [2015-26841]
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Federal Register / Vol. 80, No. 204 / Thursday, October 22, 2015 / Notices
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: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department 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 of the
collection of information on
respondents, including through the use
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. 2015–26843 Filed 10–21–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
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
64005
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.
The 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; and other assurances and
certifications. Guidance for the content
of information requested in the Uniform
Project Description is based in 45 CFR
75.203, 75.204, and 45 CFR part 75,
Appendix I.
Respondents: Applicants to ACF
Discretionary Funding Opportunity
Announcements.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
ACF Uniform Project Description (UPD) .........................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
4,562
1
60
273,720
Estimated Total Annual Burden
Hours: 273,720.
Additional Information: Copies of the
proposed collection may be obtained 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. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
VerDate Sep<11>2014
18:52 Oct 21, 2015
Jkt 238001
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–26841 Filed 10–21–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3438]
Selection of the Appropriate Package
Type Terms and Recommendations for
Labeling Injectable Medical Products
Packaged in Multiple-Dose, SingleDose, and Single-Patient-Use
Containers for Human Use; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
‘‘Selection of the Appropriate Package
Type Terms and Recommendations for
Labeling Injectable Medical Products
Packaged in Multiple-Dose, Single-Dose,
and Single-Patient-Use Containers for
Human Use.’’ This guidance has been
developed to provide industry with
FDA’s recommendations on the
selection of appropriate package type
terms and selection of appropriate
discard statements for injectable
medical products for human use,
packaged in multiple-dose, single-dose,
and single-patient-use containers. This
guidance provides FDA’s revised
definitions for single-dose and multipledose containers, and introduces the
definition of a new package type term,
‘‘single-patient-use’’ container.
Marketing applications for such
products include: New Drug
Applications (NDAs), Abbreviated New
Drug Applications (ANDAs), Biologics
License Applications (BLAs), Premarket
Approval Applications (PMAs), and
Premarket Notifications under section
510(k) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
E:\FR\FM\22OCN1.SGM
22OCN1
Agencies
[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Notices]
[Page 64005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26841]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; 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. The 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; and other assurances and certifications.
Guidance for the content of information requested in the Uniform
Project Description is based in 45 CFR 75.203, 75.204, and 45 CFR part
75, Appendix I.
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 (UPD)....... 4,562 1 60 273,720
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 273,720.
Additional Information: Copies of the proposed collection may be
obtained 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. All
requests should be identified by the title of the information
collection. Email address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication. Written comments and recommendations for the proposed
information collection should be sent directly to the following: Office
of Management and Budget, Paperwork Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration
for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-26841 Filed 10-21-15; 8:45 am]
BILLING CODE 4184-01-P