82_FR_60442 82 FR 60200 - Proposed Information Collection Activity; Comment Request

82 FR 60200 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 82, Issue 242 (December 19, 2017)

Page Range60200-60201
FR Document2017-27306

Federal Register, Volume 82 Issue 242 (Tuesday, December 19, 2017)
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60200-60201]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: ACF Generic Clearance for Mandatory Grant Financial Reports.
    OMB No.: 0970--New.
    Description: OMB has granted permission for ACF to submit a request 
for a generic clearance to be used for the financial reports used in 
the administration of mandatory grants. This clearance supports the 
Departments initiative of Generating Efficiencies through Streamlined 
Processes by employing an abbreviated process.
    If approved program offices will be at liberty to tailor a 
financial report to their specific needs rather than adhering to a 
standard form.
    Respondents: States and Territories.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Mandatory Grant Financial Reports...........             900                4                5           18,000
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours:
    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 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

[[Page 60201]]

comments and suggestions submitted within 60 days of this publication.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017-27306 Filed 12-18-17; 8:45 am]
 BILLING CODE 4184-01-P



                                                60200                          Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices

                                                age and older through educating and                             and how program effectiveness may                          responders, social service providers,
                                                training first responders and other key                         vary among different sub-populations                       laypersons including end users and
                                                community sectors on the prevention of                          and settings, and to increase knowledge                    their family and friend. All focus groups
                                                prescription drug/opioid overdose-                              of barriers and facilitators to program                    and interviews will be analyzed through
                                                related deaths, including the purchase                          implementation.                                            qualitative content analysis, including
                                                and distribution of naloxone. SAMHSA                              Researchers will use key informant                       utilization of a systematic coding
                                                is funding the grant and CDC is                                 interviews and focus groups with                           scheme.
                                                responsible for conducting the grantee                          participants in the activities enacted by                    Total burden in hours for this
                                                evaluation.                                                     the twelve state grant recipients.                         collection is 381. There are no costs to
                                                   The intended use of the resulting data                       Participants will include state                            respondents other than their time. CDC
                                                is to increase CDC and SAMHSA                                   administrators of the grant and other                      requests a three-year OMB approval to
                                                understanding of the scope and impact                           PDO/Naloxone stakeholders including                        collect the necessary project-related
                                                of the program on overdose fatalities                           advisory council members, first                            information.

                                                                                                              ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                             Average
                                                                                                                                                                                             Number of
                                                                                                                                                                          Number of                        burden per
                                                                Type of respondents                                                 Form name                                              responses per
                                                                                                                                                                         respondents                        response
                                                                                                                                                                                             respondent     (in hours)

                                                PDO/Naloxone Advisory Committee Members                       Focus Group Discussion Guide .....................                   140                 1              1.5
                                                 and Grantees.
                                                PDO/Naloxone Grantees ................................        Key Informant Interview Guide for Grantees                            36                 1                 1
                                                PDO/Naloxone Stakeholders and Partners ....                   Key Informant Interview Guide for Partners ..                         84                 1                 1
                                                PDO/Naloxone Laypersons ............................          Key    Informant    Interview       Guide           for               24                 1                 1
                                                                                                                Laypersons.
                                                All participants (PDO Naloxone grantees, ad-                  Recruitment contact script .............................             284                 1           5/60
                                                   visory committee, stakeholders and part-
                                                   ners, laypersons).
                                                PDO/Naloxone Grantees ................................        Key Informant Selection Tool .........................                12                 1          15/60



                                                Leroy A. Richardson,                                            DEPARTMENT OF HEALTH AND                                   for a generic clearance to be used for the
                                                Chief, Information Collection Review Office,                    HUMAN SERVICES                                             financial reports used in the
                                                Office of Scientific Integrity, Office of the                                                                              administration of mandatory grants.
                                                Associate Director for Science, Office of the                   Administration for Children and                            This clearance supports the
                                                Director, Centers for Disease Control and                       Families                                                   Departments initiative of Generating
                                                Prevention.                                                                                                                Efficiencies through Streamlined
                                                [FR Doc. 2017–27257 Filed 12–18–17; 8:45 am]                    Proposed Information Collection
                                                                                                                Activity; Comment Request                                  Processes by employing an abbreviated
                                                BILLING CODE 4163–18–P                                                                                                     process.
                                                                                                                Proposed Projects                                             If approved program offices will be at
                                                                                                                  Title: ACF Generic Clearance for                         liberty to tailor a financial report to their
                                                                                                                Mandatory Grant Financial Reports.                         specific needs rather than adhering to a
                                                                                                                  OMB No.: 0970—New.                                       standard form.
                                                                                                                  Description: OMB has granted
                                                                                                                permission for ACF to submit a request                        Respondents: States and Territories.

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

                                                Mandatory Grant Financial Reports .................................................................         900               4                 5            18,000



                                                  Estimated Total Annual Burden                                 Families, Office of Planning, Research                     practical utility; (b) the accuracy of the
                                                Hours:                                                          and Evaluation, 330 C Street SW,                           agency’s estimate of the burden of the
                                                  In compliance with the requirements                           Washington, DC 20201. Attn: ACF                            proposed collection of information; (c)
                                                of the Paperwork Reduction Act of 1995                          Reports Clearance Officer. Email                           the quality, utility, and clarity of the
                                                (Pub. L. 104–13, 44 U.S.C. Chap. 35), the                       address: infocollection@acf.hhs.gov. All                   information to be collected; and (d)
                                                Administration for Children and                                 requests should be identified by the title                 ways to minimize the burden of the
sradovich on DSK3GMQ082PROD with NOTICES




                                                Families is soliciting public comment                           of the information collection.                             collection of information on
                                                on the specific aspects of the                                    The Department specifically requests                     respondents, including through the use
                                                information collection described above.                         comments on: (a) Whether the proposed                      of automated collection techniques or
                                                Copies of the proposed collection of                            collection of information is necessary                     other forms of information technology.
                                                information can be obtained and                                 for the proper performance of the                          Consideration will be given to
                                                comments may be forwarded by writing                            functions of the agency, including
                                                to the Administration for Children and                          whether the information shall have


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                                                                           Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices                                          60201

                                                comments and suggestions submitted                      10903 New Hampshire Ave., Bldg. 31                       • For written/paper comments
                                                within 60 days of this publication.                     Conference Center, the Great Room (Rm.                submitted to the Dockets Management
                                                                                                        1503 B+C), Silver Spring, MD 20993–                   Staff, FDA will post your comment, as
                                                Robert Sargis,
                                                                                                        0002. Entrance for the public workshop                well as any attachments, except for
                                                Reports Clearance Officer.
                                                                                                        participants (non-FDA employees) is                   information submitted, marked and
                                                [FR Doc. 2017–27306 Filed 12–18–17; 8:45 am]            through Building 1, where routine                     identified, as confidential, if submitted
                                                BILLING CODE 4184–01–P                                  security check procedures will be                     as detailed in ‘‘Instructions.’’
                                                                                                        performed. For parking and security                      Instructions: All submissions received
                                                                                                        information, please refer to https://                 must include the Docket No. FDA–
                                                DEPARTMENT OF HEALTH AND                                www.fda.gov/AboutFDA/                                 2017–N–6716 for ‘‘New Insights for
                                                HUMAN SERVICES                                          WorkingatFDA/BuildingsandFacilities/                  Product Development and
                                                                                                        WhiteOakCampusInformation/                            Bioequivalence Assessments of Generic
                                                Food and Drug Administration
                                                                                                        ucm241740.htm.                                        Orally Inhaled and Nasal Drug
                                                [Docket No. FDA–2017–N–6716]                               You may submit comments as                         Products.’’ Received comments, those
                                                                                                        follows. Please note that late, untimely              filed in a timely manner (see
                                                New Insights for Product Development                    filed comments will not be considered.                ADDRESSES), will be placed in the docket
                                                and Bioequivalence Assessments of                       Electronic comments must be submitted                 and, except for those submitted as
                                                Generic Orally Inhaled and Nasal Drug                   on or before February 14, 2018. The                   ‘‘Confidential Submissions,’’ publicly
                                                Products; Public Workshop; Request                      https://www.regulations.gov electronic                viewable at https://www.regulations.gov
                                                for Comments                                            filing system will accept comments                    or at the Dockets Management Staff
                                                AGENCY:    Food and Drug Administration,                until midnight Eastern Time at the end                between 9 a.m. and 4 p.m., Monday
                                                HHS.                                                    of February 14, 2018. Comments                        through Friday.
                                                                                                        received by mail/hand delivery/courier                   • Confidential Submissions—To
                                                ACTION: Notice of public workshop;
                                                                                                        (for written/paper submissions) will be               submit a comment with confidential
                                                request for comments.
                                                                                                        considered timely if they are                         information that you do not wish to be
                                                SUMMARY:    The Food and Drug                           postmarked or the delivery service                    made publicly available, submit your
                                                Administration (FDA, the Agency, or                     acceptance receipt is on or before that               comments only as a written/paper
                                                we) is announcing the following public                  date.                                                 submission. You should submit two
                                                workshop entitled ‘‘New Insights for                                                                          copies total. One copy will include the
                                                Product Development and                                 Electronic Submissions                                information you claim to be confidential
                                                Bioequivalence Assessments of Generic                     Submit electronic comments in the                   with a heading or cover note that states
                                                Orally Inhaled and Nasal Drug                           following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                Products.’’ The purposes of the                           • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                                workshop are to present the outcomes                    https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                from the research projects conducted                    instructions for submitting comments.                 the claimed confidential information, in
                                                under the Generic Drug User Fee                         Comments submitted electronically,                    its consideration of comments. The
                                                Amendments (GDUFA) Regulatory                           including attachments, to https://                    second copy, which will have the
                                                Science Research Program; discuss how                   www.regulations.gov will be posted to                 claimed confidential information
                                                regulatory science initiatives have                     the docket unchanged. Because your                    redacted/blacked out, will be available
                                                helped address regulatory science                       comment will be made public, you are                  for public viewing and posted on
                                                knowledge gaps by providing insights                    solely responsible for ensuring that your             https://www.regulations.gov. Submit
                                                on factors that influence the                           comment does not include any                          both copies to the Dockets Management
                                                performance of generic orally inhaled                   confidential information that you or a                Staff. If you do not wish your name and
                                                and nasal drug products (OINDPs);                       third party may not wish to be posted,                contact information to be made publicly
                                                share the Agency’s experience on the                    such as medical information, your or                  available, you can provide this
                                                utility of novel analytical tools and                   anyone else’s Social Security number, or              information on the cover sheet and not
                                                methods developed under the regulatory                  confidential business information, such               in the body of your comments and you
                                                science initiative for generic OINDP                    as a manufacturing process. Please note               must identify this information as
                                                product development and                                 that if you include your name, contact                ‘‘confidential.’’ Any information marked
                                                bioequivalence assessments; and obtain                  information, or other information that                as ‘‘confidential’’ will not be disclosed
                                                input from the public on what, when,                    identifies you in the body of your                    except in accordance with 21 CFR 10.20
                                                where, and how analytical methods and                   comments, that information will be                    and other applicable disclosure law. For
                                                procedures should be applied in the                     posted on https://www.regulations.gov.                more information about FDA’s posting
                                                development and review of abbreviated                     • If you want to submit a comment                   of comments to public dockets, see 80
                                                new drug applications (ANDAs) for                       with confidential information that you                FR 56469, September 18, 2015, or access
                                                complex OINDPs.                                         do not wish to be made available to the               the information at: https://www.gpo.gov/
                                                                                                        public, submit the comment as a                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                DATES: The public workshop will be
                                                                                                        written/paper submission and in the                   23389.pdf.
                                                held on January 9, 2018, from 8:30 a.m.                                                                          Docket: For access to the docket to
                                                to 4:30 p.m. Individuals who wish to                    manner detailed (see ‘‘Written/Paper
                                                                                                        Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                attend the workshop must register by                                                                          electronic and written/paper comments
                                                December 30, 2017. Submit either                        Written/Paper Submissions                             received, go to https://
sradovich on DSK3GMQ082PROD with NOTICES




                                                electronic or written comments on this                    Submit written/paper submissions as                 www.regulations.gov and insert the
                                                public workshop by February 14, 2018.                   follows:                                              docket number, found in brackets in the
                                                See the SUPPLEMENTARY INFORMATION                         • Mail/Hand delivery/Courier (for                   heading of this document, into the
                                                section for registration date and                       written/paper submissions): Dockets                   ‘‘Search’’ box and follow the prompts
                                                information.                                            Management Staff (HFA–305), Food and                  and/or go to the Dockets Management
                                                ADDRESSES: The public workshop will                     Drug Administration, 5630 Fishers                     Staff, 5630 Fishers Lane, Rm. 1061,
                                                be held at FDA White Oak Campus,                        Lane, Rm. 1061, Rockville, MD 20852.                  Rockville, MD 20852.


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Document Created: 2017-12-19 01:31:35
Document Modified: 2017-12-19 01:31:35
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 Citation82 FR 60200 

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