Proposed Information Collection Activity; Comment Request Proposed Projects:, 89108-89109 [2016-29583]
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89108
Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
Annex A: Status of Application Report ............................................................
Annex B: Application for Enforcement of a Decision Made or Recognized in
the Requested State, including restricted information on the applicant ......
Annex B: Status of Application Report, Article 12 ...........................................
Annex C: Application for Establishment of a Decision, including restricted
information on the Applicant ........................................................................
Annex C: Status of Application Report—Article 12 .........................................
Annex D: Application for Modification of a Decision, including Restricted Information on the Applicant ...........................................................................
Annex D: Status of Application Report—Article 12 .........................................
Annex E: Financial Circumstances Form ........................................................
Estimated Total Annual Burden
Hours: 13,478.
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, 330
C Street SW., Washington, DC 20201.
Attention 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.
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
54
37
.33
659
54
54
19
37
.5
.33
513
659
54
54
5
9
.5
.33
135
160
54
54
54
5
9
46
.5
.33
2
135
160
4,968
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–29590 Filed 12–8–16; 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 Proposed
Projects:
Title: ADP & Services Conditions for
FFP for ACF.
OMB No.: 0970–0417.
Description: State child support
agencies are required to establish and
operate a federally approved statewide
automated data processing and
information retrieval system to assist in
child support enforcement. States are
required to submit an initial advance
automated data processing planning
document (APD) containing information
to assist the Secretary of the Department
of Health and Human Services in
determining if the state computerized
support enforcement system meets
federal requirements and providing
federal approval. States are also
required to submit annually an updated
APD for oversight purposes. Based on
assessment of the information provided
in the initial or updated APDs, states
that do not meet federal requirement
approval will need to complete an
independent verification and validation.
The Advance Planning Document
(APD) process, established in the rules
at 45 CFR part 95, Subpart F, is the
procedure by which States request and
obtain approval for Federal financial
participation in their cost of acquiring
Automatic Data Processing (ADP)
equipment and services. State agencies
that submit APD requests provide the
Department of Health and Human
Services (HHS) with the following
information necessary to determine the
States’ needs to acquire the requested
ADP equipment and/or services:
Respondents: States.
ANNUAL BURDEN ESTIMATES
Number of
respondents
mstockstill on DSK3G9T082PROD with NOTICES
Instrument
RFP and Contract ............................................................................................
Emergency Funding Request ..........................................................................
Biennial Reports ..............................................................................................
Advance Planning Document ..........................................................................
Operational Advance Planning Document .......................................................
Independent Verification and Validation (ongoing) .........................................
Independent Verification and Validation (semiannually) .................................
Independent Verification and Validation (quarterly) ........................................
System Certification .........................................................................................
Estimated Total Annual Burden
Hours: 6,414.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
VerDate Sep<11>2014
18:13 Dec 08, 2016
Jkt 241001
54
5
54
34
20
3
1
1
1
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1.5
.1
1
1.2
1
4
2
4
1
Average
burden hours
per response
4
2
1.50
120
30
10
16
30
240
Total burden
hours
324
1
81
4,896
600
120
32
120
240
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
E:\FR\FM\09DEN1.SGM
09DEN1
Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices
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. 2016–29583 Filed 12–8–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4096]
Final Assessment of the Program for
Enhanced Review Transparency and
Communication; Public Meeting and
Establishment of Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
establishment of docket, request for
comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to obtain
comments on the final assessment of the
Program for Enhanced Review
Transparency and Communication for
New Molecular Entity (NME) New Drug
Applications (NDAs) and Original
Biologics License Applications (BLAs)
(the Program). FDA is also announcing
a public meeting where the final
assessment will be discussed and public
stakeholders may present their views on
the Program to date. The Program is part
of the FDA performance commitments
under the fifth authorization of the
Prescription Drug User Fee Act
(PDUFA), which enables FDA to collect
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:13 Dec 08, 2016
Jkt 241001
user fees for the review of human drug
and biologics applications for fiscal
years (FYs) 2013–2017. The Program is
described in detail in section II.B of the
document entitled ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through
2017.’’ The Program is being evaluated
by an independent contractor with
expertise in assessing the quality and
efficiency of pharmaceutical and
biopharmaceutical development and
regulatory review programs. As part of
FDA’s performance commitments, FDA
is providing a period for public
comment on the final assessment of the
Program.
DATES: The public meeting will be held
on March 27, 2017, from 10 a.m. to 1
p.m. Public comments will be accepted
through April 3, 2017. See the
ADDRESSES section for information about
submitting comments to the public
docket. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 2,
Conference Room 2047 E, Silver Spring,
MD 20993–0002. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
Electronic Submissions
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
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Frm 00068
Fmt 4703
Sfmt 4703
89109
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–N–4096. Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov 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.
E:\FR\FM\09DEN1.SGM
09DEN1
Agencies
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89108-89109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29583]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects:
Title: ADP & Services Conditions for FFP for ACF.
OMB No.: 0970-0417.
Description: State child support agencies are required to establish
and operate a federally approved statewide automated data processing
and information retrieval system to assist in child support
enforcement. States are required to submit an initial advance automated
data processing planning document (APD) containing information to
assist the Secretary of the Department of Health and Human Services in
determining if the state computerized support enforcement system meets
federal requirements and providing federal approval. States are also
required to submit annually an updated APD for oversight purposes.
Based on assessment of the information provided in the initial or
updated APDs, states that do not meet federal requirement approval will
need to complete an independent verification and validation.
The Advance Planning Document (APD) process, established in the
rules at 45 CFR part 95, Subpart F, is the procedure by which States
request and obtain approval for Federal financial participation in
their cost of acquiring Automatic Data Processing (ADP) equipment and
services. State agencies that submit APD requests provide the
Department of Health and Human Services (HHS) with the following
information necessary to determine the States' needs to acquire the
requested ADP equipment and/or services:
Respondents: States.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
RFP and Contract................................ 54 1.5 4 324
Emergency Funding Request....................... 5 .1 2 1
Biennial Reports................................ 54 1 1.50 81
Advance Planning Document....................... 34 1.2 120 4,896
Operational Advance Planning Document........... 20 1 30 600
Independent Verification and Validation 3 4 10 120
(ongoing)......................................
Independent Verification and Validation 1 2 16 32
(semiannually).................................
Independent Verification and Validation 1 4 30 120
(quarterly)....................................
System Certification............................ 1 1 240 240
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,414.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), 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
[[Page 89109]]
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. 2016-29583 Filed 12-8-16; 8:45 am]
BILLING CODE 4184-01-P