Proposed Information Collection Activity; Comment Request, 23302-23303 [2016-09055]
Download as PDF
<![CDATA[
23302
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
submissions to Congress. Financial
management of the program would be
seriously compromised if the
expenditure data were not collected.
45 CFR part 286 Subpart E requires
the strictest controls on funding
requirements, which necessities review
of documentation in support of Tribal
expenditures for reimbursement.
Comments received from previous
efforts to implement a similar Tribal
TANF report Form ACF–196T were
used to guide ACF in the development
of the product presented with this
submittal.
Respondents: All approved Tribal
TANF Agencies. Those with
consolidated Tribal TANF programs
plans under 102–477 may submit the
Tribal TANF Financial Report to BIA
with a copy to: ACF Division of
Mandatory Grants, 330 C Street SW.,
Washington, DC 20201. Or at their
convenience may elect to use the OnLine Data Collection System to
electronically submit their quarterly
Tribal TANF Financial Report.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total burden
hours
ACF–196T ........................................................................................................
72
4
1.25
360
Estimated Total Annual Burden
Hours: 360.
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, 330 C Street SW.,
Washington DC 20201. 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. 2016–09123 Filed 4–19–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
OMB No.: 0970–0195.
Description: This form is used by
Tribes and Tribal Organizations that
have been approved as grantees to
administer the Child Care and
Development Fund program (CCDF).
This form is submitted annually to
report CCDF program expenditures to
the Administration for Children and
Families.
The authority to collect and report
this information can be found in Section
658G of the Child Care and
Development Block Grant Act of 1990
(Pub. L. 101–508), as amended, and in
Federal regulations at 45 CFR 98.65(g)
and 98.67(c)(1) which authorize the
Secretary to require financial reports as
necessary.
Respondents: Tribes and Tribal
Organizations.
Proposed Projects
Title: Form ACF–696T, ‘‘Child Care
and Development Fund Annual
Financial Report for Tribes’’
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Total burden
hours
Form ACF–696T, ‘‘Child Care and Development Fund Annual Financial Report for Tribes’’ .............................................................................................
Lhorne on DSK5TPTVN1PROD with NOTICES
Instrument
272
1
6
1,632
Estimated Total Annual Burden
Hours: 1,632.
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.
VerDate Sep<11>2014
14:53 Apr 19, 2016
Jkt 238001
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: infocollection@acf.hhs.gov. All
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
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. 2016–09055 Filed 4–19–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0973]
Comparability Protocols for Human
Drugs and Biologics: Chemistry,
Manufacturing, and Controls
Information; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Comparability
Protocols for Human Drugs and
Biologics: Chemistry, Manufacturing,
and Controls Information.’’ This
document is a revised version of a draft
guidance that published in February
2003 entitled ‘‘Comparability Protocols:
Chemistry, Manufacturing, and Controls
Information.’’ A related draft guidance
entitled ‘‘Comparability Protocols—
Protein Drug Products and Biological
Products—Chemistry, Manufacturing,
and Controls Information,’’ that
published in September 2003, was
withdrawn on May 6, 2015.
The revised draft guidance provides
recommendations to human drug and
biologics manufacturers on
implementing a chemistry,
manufacturing, and controls (CMC)
postapproval change(s) through the use
of a comparability protocol (CP). By
using a CP, manufacturers who fall
within the scope of this guidance will
not have to submit commercial-scale
CMC information on postchange
products to FDA before making the
proposed change. This draft guidance is
intended to establish a framework to
promote manufacturing of quality drug
products.
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:53 Apr 19, 2016
Jkt 238001
Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by June 20, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Comments
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public submit the comment as a written/
paper submission and in the manner
detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–0973 for ‘‘Comparability
Protocols for Human Drugs and
Biologics: Chemistry, Manufacturing,
and Controls Information.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
23303
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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Stephen Moore, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 21, Rm.
2012, 10903 New Hampshire Ave.,
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23302-23303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09055]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Form ACF-696T, ``Child Care and Development Fund Annual
Financial Report for Tribes''
OMB No.: 0970-0195.
Description: This form is used by Tribes and Tribal Organizations
that have been approved as grantees to administer the Child Care and
Development Fund program (CCDF). This form is submitted annually to
report CCDF program expenditures to the Administration for Children and
Families.
The authority to collect and report this information can be found
in Section 658G of the Child Care and Development Block Grant Act of
1990 (Pub. L. 101-508), as amended, and in Federal regulations at 45
CFR 98.65(g) and 98.67(c)(1) which authorize the Secretary to require
financial reports as necessary.
Respondents: Tribes and Tribal Organizations.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Form ACF-696T, ``Child Care and Development 272 1 6 1,632
Fund Annual Financial Report for Tribes''..
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,632.
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, 330 C Street SW., Washington DC
20201. 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
[[Page 23303]]
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. 2016-09055 Filed 4-19-16; 8:45 am]
BILLING CODE 4184-01-P
