82 FR 48089 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 198 (October 16, 2017)

Page Range		48089-48090
FR Document		2017-22294

Federal Register, Volume 82 Issue 198 (Monday, October 16, 2017)

[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48089-48090]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22294]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

    Title: Community-Based Family Resource and Support Grants (Name 
changed to Child Abuse Prevention Program--OIS notified 6/2007).
    OMB No.: 0970-0155.
    Description: The Program Instruction, prepared in response to the 
enactment of Community-Based Child Abuse Prevention (CBCAP) program, as 
set forth in Title II of the Child Abuse Prevention and Treatment 
Reauthorization Act of 2010 (Pub. L. 111-320) or CAPTA, provides 
direction to the states and territories to accomplish the purposes of 
(1) supporting community-based efforts to develop, operate, expand, and 
where appropriate to network, initiatives aimed at the prevention of 
child abuse and neglect, and to support networks of coordinated 
resources and activities to better strengthen and support families to 
reduce the likelihood of child abuse and neglect, and; (2) fostering an 
understanding, appreciation, and knowledge of diverse populations in 
order to be effective in preventing and treating child abuse and 
neglect. This Program Instruction contains information collection 
requirements that are found in CAPTA and pursuant to receiving a grant 
award. The information submitted will be used by the agency to ensure 
compliance with the statute, complete the calculation of the grant 
award entitlement, and provide training and technical assistance to the 
grantee.
    Respondents: State Governments.

[[Page 48090]]



                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Application.....................................              52               1              40           2,080
Annual Report...................................              52               1              24           1,248
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 3,328.
    In compliance with the requirements of Section 3506(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, 330 C Street SW., Washington, DC 
20201, Attn: ACF Reports Clearance Officer. Email address: 
[email protected]. 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.

Mary Jones,
ACF/OPRE Reports Clearance Officer.
[FR Doc. 2017-22294 Filed 10-13-17; 8:45 am]
 BILLING CODE 4184-29-P

48090 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Application ....................................................................................................... 52 1 40 2,080
Annual Report .................................................................................................. 52 1 24 1,248

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Guidance for Industry on Fees for
Hours: 3,328. HUMAN SERVICES Human Drug Compounding
In compliance with the requirements Outsourcing Facilities Under Sections
of Section 3506(c)(2)(A) of the Food and Drug Administration 503B and 744K of the FD&C Act OMB
Control Number 0910–0776—Extension
Paperwork Reduction Act of 1995, the
Administration for Children and [Docket No. FDA–2014–D–0329] This information collection supports
Families is soliciting public comment the Agency’s guidance on fees for
on the specific aspects of the Agency Information Collection human drug compounding outsourcing
Activities; Submission for Office of facilities under the Federal Food, Drug,
information collection described above.
Management and Budget Review; and Cosmetic Act (the FD&C Act). On
Copies of the proposed collection of
Comment Request; Guidance for November 27, 2013, the President
information can be obtained and
Industry on Fees for Human Drug signed the Drug Quality and Security
comments may be forwarded by writing
Compounding Outsourcing Facilities Act (DQSA) (Pub. L. 113–54) into law.
to the Administration for Children and The DQSA added a new section, 503B
Under the Federal Food, Drug, and
Families, Office of Planning, Research, (21 U.S.C. 353B), to the FD&C Act,
Cosmetic Act
and Evaluation, 330 C Street SW., creating a category of entities called
Washington, DC 20201, Attn: ACF AGENCY: Food and Drug Administration, ‘‘outsourcing facilities.’’ Outsourcing
Reports Clearance Officer. Email HHS. facilities, as defined in section
address: infocollection@acf.hhs.gov. All 503B(d)(4) of the FD&C Act, are
requests should be identified by the title ACTION: Notice. facilities that meet certain requirements
of the information collection. described in section 503B, including
SUMMARY: The Food and Drug registering with FDA as an outsourcing
The Department specifically requests
Administration (FDA) is announcing facility and paying associated fees. Drug
comments on (a) whether the proposed
that a proposed collection of products compounded in an
collection of information is necessary
information has been submitted to the outsourcing facility can qualify for
for the proper performance of the
Office of Management and Budget exemptions from the FDA approval
functions of the agency, including (OMB) for review and clearance under requirements in section 505 of the FD&C
whether the information shall have the Paperwork Reduction Act of 1995. Act (21 U.S.C. 355), and the requirement
practical utility; (b) the accuracy of the
DATES: Fax written comments on the to label products with adequate
agency’s estimate of the burden of the directions for use under section
proposed collection of information; (c) collection of information by November
502(f)(1) of the FD&C Act (21 U.S.C.
the quality, utility, and clarity of the 15, 2017.
352(f)(1)), if the requirements in section
information to be collected; and (d) ADDRESSES: To ensure that comments on 503B of the FD&C Act are met.
ways to minimize the burden of the the information collection are received, The guidance is intended for entities
collection of information on OMB recommends that written that compound human drugs and elect
respondents, including through the use comments be faxed to the Office of to register as outsourcing facilities
of automated collection techniques or Information and Regulatory Affairs, under section 503B of the FD&C Act.
other forms of information technology. OMB, Attn: FDA Desk Officer, Fax: 202– Once an entity has elected to register as
Consideration will be given to 395–7285, or emailed to oira_ an outsourcing facility, it must pay
comments and suggestions submitted submission@omb.eop.gov. All certain fees to be registered as an
within 60 days of this publication. comments should be identified with the outsourcing facility. The guidance
OMB control number 0910–0776. Also describes the types and amounts of fees
Mary Jones, that outsourcing facilities must pay, the
include the FDA docket number found
ACF/OPRE Reports Clearance Officer. in brackets in the heading of this adjustments to fees required by law, the
[FR Doc. 2017–22294 Filed 10–13–17; 8:45 am] document. way in which outsourcing facilities may
BILLING CODE 4184–29–P
submit payment to FDA, the
FOR FURTHER INFORMATION CONTACT: consequences of outsourcing facilities’
Domini Bean, Office of Operations, failure to pay fees, and the way an
Food and Drug Administration, Three outsourcing facility may qualify as a
White Flint North, 10A63, 11601 small business to obtain a reduction in
Landsdown St., North Bethesda, MD fees.
20852, 301–796–5733, PRAStaff@ In the Federal Register of June 15,
ethrower on DSK3G9T082PROD with NOTICES

fda.hhs.gov. 2017 (82 FR 27493), we published a 60-
day notice requesting public comment
SUPPLEMENTARY INFORMATION: In on the proposed extension of this
compliance with 44 U.S.C. 3507, FDA collection of information. No comments
has submitted the following proposed were received. We therefore estimate the
collection of information to OMB for burden associated with the information
review and clearance. collection as follows:

VerDate Sep<11>2014 16:59 Oct 13, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1

Document Created: 2017-10-14 01:43:04
Document Modified: 2017-10-14 01:43:04

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		82 FR 48089

82 FR 48089 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 82, Issue 198 (October 16, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families