81_FR_89345 81 FR 89108 - Proposed Information Collection Activity; Comment Request Proposed Projects:

81 FR 89108 - Proposed Information Collection Activity; Comment Request Proposed Projects:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 81, Issue 237 (December 9, 2016)

Page Range89108-89109
FR Document2016-29583

Federal Register, Volume 81 Issue 237 (Friday, December 9, 2016)
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89108-89109]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29583]


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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: 
[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.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-29583 Filed 12-8-16; 8:45 am]
 BILLING CODE 4184-01-P



                                                  89108                                 Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices

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

                                                  Annex A: Status of Application Report ............................................................                            54               37               .33            659
                                                  Annex B: Application for Enforcement of a Decision Made or Recognized in
                                                    the Requested State, including restricted information on the applicant ......                                               54               19                .5            513
                                                  Annex B: Status of Application Report, Article 12 ...........................................                                 54               37               .33            659
                                                  Annex C: Application for Establishment of a Decision, including restricted
                                                    information on the Applicant ........................................................................                       54                5                .5            135
                                                  Annex C: Status of Application Report—Article 12 .........................................                                    54                9               .33            160
                                                  Annex D: Application for Modification of a Decision, including Restricted In-
                                                    formation on the Applicant ...........................................................................                      54                5                .5            135
                                                  Annex D: Status of Application Report—Article 12 .........................................                                    54                9               .33            160
                                                  Annex E: Financial Circumstances Form ........................................................                                54               46                 2          4,968



                                                    Estimated Total Annual Burden                                          Attn: Desk Officer for the                                  document (APD) containing information
                                                  Hours: 13,478.                                                         Administration for Children and                               to assist the Secretary of the Department
                                                    Additional Information: Copies of the                                Families.                                                     of Health and Human Services in
                                                  proposed collection may be obtained by                                                                                               determining if the state computerized
                                                                                                                         Robert Sargis,
                                                  writing to the Administration for                                                                                                    support enforcement system meets
                                                                                                                         Reports Clearance Officer.
                                                                                                                                                                                       federal requirements and providing
                                                  Children and Families, Office of                                       [FR Doc. 2016–29590 Filed 12–8–16; 8:45 am]
                                                                                                                                                                                       federal approval. States are also
                                                  Planning, Research and Evaluation, 330                                 BILLING CODE 4184–01–P                                        required to submit annually an updated
                                                  C Street SW., Washington, DC 20201.                                                                                                  APD for oversight purposes. Based on
                                                  Attention Reports Clearance Officer. All                                                                                             assessment of the information provided
                                                  requests should be identified by the title                             DEPARTMENT OF HEALTH AND
                                                                                                                                                                                       in the initial or updated APDs, states
                                                  of the information collection. Email                                   HUMAN SERVICES
                                                                                                                                                                                       that do not meet federal requirement
                                                  address: infocollection@acf.hhs.gov.                                                                                                 approval will need to complete an
                                                                                                                         Administration for Children and
                                                    OMB Comment: OMB is required to                                      Families                                                      independent verification and validation.
                                                  make a decision concerning the                                                                                                          The Advance Planning Document
                                                  collection of information between 30                                   Proposed Information Collection                               (APD) process, established in the rules
                                                  and 60 days after publication of this                                  Activity; Comment Request Proposed                            at 45 CFR part 95, Subpart F, is the
                                                  document in the Federal Register.                                      Projects:                                                     procedure by which States request and
                                                  Therefore, a comment is best assured of                                  Title: ADP & Services Conditions for                        obtain approval for Federal financial
                                                  having its full effect if OMB receives it                              FFP for ACF.                                                  participation in their cost of acquiring
                                                  within 30 days of publication. Written                                   OMB No.: 0970–0417.                                         Automatic Data Processing (ADP)
                                                  comments and recommendations for the                                     Description: State child support                            equipment and services. State agencies
                                                  proposed information collection should                                 agencies are required to establish and                        that submit APD requests provide the
                                                  be sent directly to the following: Office                              operate a federally approved statewide                        Department of Health and Human
                                                  of Management and Budget Paperwork                                     automated data processing and                                 Services (HHS) with the following
                                                  Reduction Project.                                                     information retrieval system to assist in                     information necessary to determine the
                                                                                                                         child support enforcement. States are                         States’ needs to acquire the requested
                                                    Email: OIRA_SUBMISSION@                                                                                                            ADP equipment and/or services:
                                                                                                                         required to submit an initial advance
                                                  OMB.EOP.GOV.                                                           automated data processing planning                               Respondents: States.

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

                                                  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 (ongoing) .........................................                                    3                 4               10            120
                                                  Independent Verification and Validation (semiannually) .................................                                       1                 2               16             32
                                                  Independent Verification and Validation (quarterly) ........................................                                   1                 4               30            120
                                                  System Certification .........................................................................................                 1                 1              240            240
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                                                    Estimated Total Annual Burden                                        (Pub. L. 104–13, 44 U.S.C. Chap 35), the                      information collection described above.
                                                  Hours: 6,414.                                                          Administration for Children and                               Copies of the proposed collection of
                                                    In compliance with the requirements                                  Families is soliciting public comment                         information can be obtained and
                                                  of the Paperwork Reduction Act of 1995                                 on the specific aspects of the                                comments may be forwarded by writing



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                                                                               Federal Register / Vol. 81, No. 237 / Friday, December 9, 2016 / Notices                                          89109

                                                  to the Administration for Children and                  user fees for the review of human drug                do not wish to be made available to the
                                                  Families, Office of Planning, Research                  and biologics applications for fiscal                 public, submit the comment as a
                                                  and Evaluation, 330 C Street SW.,                       years (FYs) 2013–2017. The Program is                 written/paper submission and in the
                                                  Washington, DC 20201. Attn: ACF                         described in detail in section II.B of the            manner detailed (see ‘‘Written/Paper
                                                  Reports Clearance Officer. Email                        document entitled ‘‘PDUFA                             Submissions’’ and ‘‘Instructions’’).
                                                  address: infocollection@acf.hhs.gov. All                Reauthorization Performance Goals and
                                                                                                                                                                Written/Paper Submissions
                                                  requests should be identified by the title              Procedures Fiscal Years 2013 through
                                                  of the information collection.                          2017.’’ The Program is being evaluated                   Submit written/paper submissions as
                                                    The Department specifically requests                  by an independent contractor with                     follows:
                                                  comments on: (a) Whether the proposed                   expertise in assessing the quality and                   • Mail/Hand delivery/Courier (for
                                                  collection of information is necessary                  efficiency of pharmaceutical and                      written/paper submissions): Division of
                                                  for the proper performance of the                       biopharmaceutical development and                     Dockets Management (HFA–305), Food
                                                  functions of the agency, including                      regulatory review programs. As part of                and Drug Administration, 5630 Fishers
                                                  whether the information shall have                      FDA’s performance commitments, FDA                    Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                          is providing a period for public                         • For written/paper comments
                                                  practical utility; (b) the accuracy of the
                                                                                                          comment on the final assessment of the                submitted to the Division of Dockets
                                                  agency’s estimate of the burden of the
                                                                                                          Program.                                              Management, FDA will post your
                                                  proposed collection of information; (c)
                                                                                                          DATES: The public meeting will be held
                                                                                                                                                                comment, as well as any attachments,
                                                  the quality, utility, and clarity of the
                                                                                                          on March 27, 2017, from 10 a.m. to 1                  except for information submitted,
                                                  information to be collected; and (d)
                                                                                                          p.m. Public comments will be accepted                 marked and identified, as confidential,
                                                  ways to minimize the burden of the
                                                                                                          through April 3, 2017. See the                        if submitted as detailed in
                                                  collection of information on
                                                                                                          ADDRESSES section for information about
                                                                                                                                                                ‘‘Instructions.’’
                                                  respondents, including through the use                                                                           Instructions: All submissions received
                                                  of automated collection techniques or                   submitting comments to the public
                                                                                                                                                                must include the Docket No. FDA–
                                                  other forms of information technology.                  docket. See the SUPPLEMENTARY
                                                                                                                                                                2016–N–4096. Received comments will
                                                  Consideration will be given to                          INFORMATION section for registration date
                                                                                                                                                                be placed in the docket and, except for
                                                  comments and suggestions submitted                      and information.
                                                                                                                                                                those submitted as ‘‘Confidential
                                                  within 60 days of this publication.                     ADDRESSES: The public meeting will be                 Submissions,’’ publicly viewable at
                                                                                                          held at the FDA White Oak Campus,                     http://www.regulations.gov or at the
                                                  Robert Sargis,
                                                                                                          10903 New Hampshire Ave., Bldg. 2,                    Division of Dockets Management
                                                  Reports Clearance Officer.                              Conference Room 2047 E, Silver Spring,
                                                  [FR Doc. 2016–29583 Filed 12–8–16; 8:45 am]
                                                                                                                                                                between 9 a.m. and 4 p.m., Monday
                                                                                                          MD 20993–0002. Entrance for the public                through Friday.
                                                  BILLING CODE 4184–01–P                                  meeting participants (non-FDA                            • Confidential Submissions—To
                                                                                                          employees) is through Building 1 where                submit a comment with confidential
                                                                                                          routine security check procedures will                information that you do not wish to be
                                                  DEPARTMENT OF HEALTH AND                                be performed. For more information on
                                                  HUMAN SERVICES                                                                                                made publicly available, submit your
                                                                                                          parking and security procedures, please               comments only as a written/paper
                                                                                                          refer to http://www.fda.gov/AboutFDA/                 submission. You should submit two
                                                  Food and Drug Administration
                                                                                                          WorkingatFDA/BuildingsandFacilities/                  copies total. One copy will include the
                                                  [Docket No. FDA–2016–N–4096]                            WhiteOakCampusInformation/                            information you claim to be confidential
                                                                                                          ucm241740.htm.                                        with a heading or cover note that states
                                                  Final Assessment of the Program for                        You may submit comments as                         ‘‘THIS DOCUMENT CONTAINS
                                                  Enhanced Review Transparency and                        follows:                                              CONFIDENTIAL INFORMATION.’’ The
                                                  Communication; Public Meeting and
                                                                                                          Electronic Submissions                                Agency will review this copy, including
                                                  Establishment of Docket
                                                                                                            Submit electronic comments in the                   the claimed confidential information, in
                                                  AGENCY:    Food and Drug Administration,                following way:                                        its consideration of comments. The
                                                  HHS.                                                      • Federal eRulemaking Portal: http://               second copy, which will have the
                                                  ACTION: Notice of public meeting and                    www.regulations.gov. Follow the                       claimed confidential information
                                                  establishment of docket, request for                    instructions for submitting comments.                 redacted/blacked out, will be available
                                                  comments.                                               Comments submitted electronically,                    for public viewing and posted on http://
                                                                                                          including attachments, to http://                     www.regulations.gov. Submit both
                                                  SUMMARY:   The Food and Drug                            www.regulations.gov will be posted to                 copies to the Division of Dockets
                                                  Administration (FDA) is announcing the                  the docket unchanged. Because your                    Management. If you do not wish your
                                                  establishment of a docket to obtain                     comment will be made public, you are                  name and contact information to be
                                                  comments on the final assessment of the                 solely responsible for ensuring that your             made publicly available, you can
                                                  Program for Enhanced Review                             comment does not include any                          provide this information on the cover
                                                  Transparency and Communication for                      confidential information that you or a                sheet and not in the body of your
                                                  New Molecular Entity (NME) New Drug                     third party may not wish to be posted,                comments and you must identify this
                                                  Applications (NDAs) and Original                        such as medical information, your or                  information as ‘‘confidential.’’ Any
                                                  Biologics License Applications (BLAs)                   anyone else’s Social Security number, or              information marked as ‘‘confidential’’
                                                  (the Program). FDA is also announcing                   confidential business information, such               will not be disclosed except in
                                                  a public meeting where the final                                                                              accordance with 21 CFR 10.20 and other
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                          as a manufacturing process. Please note
                                                  assessment will be discussed and public                 that if you include your name, contact                applicable disclosure law. For more
                                                  stakeholders may present their views on                 information, or other information that                information about FDA’s posting of
                                                  the Program to date. The Program is part                identifies you in the body of your                    comments to public dockets, see 80 FR
                                                  of the FDA performance commitments                      comments, that information will be                    56469, September 18, 2015, or access
                                                  under the fifth authorization of the                    posted on http://www.regulations.gov.                 the information at: http://www.fda.gov/
                                                  Prescription Drug User Fee Act                            • If you want to submit a comment                   regulatoryinformation/dockets/
                                                  (PDUFA), which enables FDA to collect                   with confidential information that you                default.htm.


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Document Created: 2018-02-14 09:03:46
Document Modified: 2018-02-14 09:03:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 89108 

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