80_FR_67115 80 FR 66905 - Submission for OMB Review; Comment Request

80 FR 66905 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 210 (October 30, 2015)

Page Range66905-66906
FR Document2015-27666

Federal Register, Volume 80 Issue 210 (Friday, October 30, 2015)
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Notices]
[Pages 66905-66906]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27666]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Administration for Native Americans Annual Data Collection 
(Annual Data Report).
    OMB No.: New collection.
    Description: Content and formatting changes are being made to the 
Objective Progress Report (OPR). Content changes are being made to the 
OPR, now known as the Annual Data Report (ADR) previously approved 
under information collection OMB No. 0980-0204. ANA has determined that 
the requirement for ANA grantees to submit information about the 
project activities on quarterly basis creates undue burden for 
Grantees. Therefore, ANA has reformatted the OPR to require Grantees 
submit an annual report instead of quarterly report when reporting on 
partnerships, youth and elder engagement, impact indicators, community 
involvement etc. This will reduce the administrative burden on 
Grantees, especially the smaller organizations. The majority of content 
being requested from the grantees essentially remain same except for 
the frequency of reporting. The other sections of the document with 
reference to ``quarterly'' information will be changed to reflect the 
shift from four-times a year reporting requirement to once per year and 
once at the end of the project period.
    Respondents: Tribal Government, Native non-profit organizations, 
Tribal Colleges & Universities receiving ANA funding.

Annual Burden Estimates

    The following is the hour of burden estimate for this information 
collection:

----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
ADR.........................................             275                2                2              275
----------------------------------------------------------------------------------------------------------------


[[Page 66906]]

    Estimated Total Annual Burden Hours: 275.
    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, 370 L'Enfant Promenade 
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All 
requests should be identified by the title of the information 
collection. Email address: [email protected].
    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: 
[email protected], Attn: Desk Officer for the Administration 
for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-27666 Filed 10-29-15; 8:45 am]
BILLING CODE 4184-01-P



                                                                                       Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices                                                                66905

                                                To obtain copies of a supporting                                         Satisfaction Surveys; Use: This                                   Dated: October 26, 2015.
                                              statement and any related forms for the                                    collection of information is necessary to                      William N. Parham, III,
                                              proposed collection(s) summarized in                                       enable the Agency to garner customer                           Director, Paperwork Reduction Staff, Office
                                              this notice, you may make your request                                     and stakeholder feedback in an efficient,                      of Strategic Operations and Regulatory
                                              using one of following:                                                    timely manner, in accordance with our                          Affairs.
                                                1. Access CMS’ Web site address at                                       commitment to improving service                                [FR Doc. 2015–27619 Filed 10–29–15; 8:45 am]
                                              http://www.cms.hhs.gov/                                                    delivery. The information collected                            BILLING CODE 4120–01–P
                                              PaperworkReductionActof1995.                                               from our customers and stakeholders
                                                2. Email your request, including your                                    will help ensure that users have an
                                              address, phone number, OMB number,                                         effective, efficient, and satisfying                           DEPARTMENT OF HEALTH AND
                                              and CMS document identifier, to                                            experience with the Agency’s programs.                         HUMAN SERVICES
                                              Paperwork@cms.hhs.gov.                                                     This feedback will provide insights into
                                                3. Call the Reports Clearance Office at                                  customer or stakeholder perceptions,                           Administration for Children and
                                              (410) 786–1326.                                                            experiences and expectations, provide                          Families
                                              FOR FURTHER INFORMATION CONTACT:                                           an early warning of issues with service,
                                              Reports Clearance Office at (410) 786–                                                                                                    Submission for OMB Review;
                                                                                                                         or focus attention on areas where
                                              1326.                                                                                                                                     Comment Request
                                                                                                                         communication, training or changes in
                                              SUPPLEMENTARY INFORMATION:                                                 operations might improve delivery of                             Title: Administration for Native
                                                                                                                         products or services. These collections                        Americans Annual Data Collection
                                              Contents
                                                                                                                         will allow for ongoing, collaborative and                      (Annual Data Report).
                                                This notice sets out a summary of the                                    actionable communications between the
                                              use and burden associated with the                                         Agency and its customers and                                     OMB No.: New collection.
                                              following information collections. More                                    stakeholders. It will also allow feedback                        Description: Content and formatting
                                              detailed information can be found in                                       to contribute directly to the                                  changes are being made to the Objective
                                              each collection’s supporting statement                                     improvement of program management.                             Progress Report (OPR). Content changes
                                              and associated materials (see                                                                                                             are being made to the OPR, now known
                                                                                                                            Collecting voluntary customer
                                              ADDRESSES).                                                                                                                               as the Annual Data Report (ADR)
                                                                                                                         feedback is the least burdensome, most
                                              CMS–10415 Generic Clearance for the                                        effective way for the Agency to                                previously approved under information
                                              Collection Customer Satisfaction                                           determine whether or not its public Web                        collection OMB No. 0980–0204. ANA
                                              Surveys                                                                    sites are useful to and used by its                            has determined that the requirement for
                                                                                                                         customers. Generic clearance is needed                         ANA grantees to submit information
                                                Under the PRA (44 U.S.C. 3501–                                                                                                          about the project activities on quarterly
                                              3520), federal agencies must obtain                                        to ensure that the Agency can
                                                                                                                         continuously improve its Web sites                             basis creates undue burden for Grantees.
                                              approval from the Office of Management                                                                                                    Therefore, ANA has reformatted the
                                              and Budget (OMB) for each collection of                                    though regular surveys developed from
                                                                                                                         these pre-defined questions. Surveying                         OPR to require Grantees submit an
                                              information they conduct or sponsor.                                                                                                      annual report instead of quarterly report
                                              The term ‘‘collection of information’’ is                                  the Agency Web sites on a regular,
                                                                                                                         ongoing basis will help ensure that                            when reporting on partnerships, youth
                                              defined in 44 U.S.C. 3502(3) and 5 CFR                                                                                                    and elder engagement, impact
                                              1320.3(c) and includes agency requests                                     users have an effective, efficient, and
                                                                                                                         satisfying experience on any of the Web                        indicators, community involvement etc.
                                              or requirements that members of the                                                                                                       This will reduce the administrative
                                              public submit reports, keep records, or                                    sites, maximizing the impact of the
                                                                                                                         information and resulting in optimum                           burden on Grantees, especially the
                                              provide information to a third party.                                                                                                     smaller organizations. The majority of
                                              Section 3506(c)(2)(A) of the PRA                                           benefit for the public. The surveys will
                                                                                                                         ensure that this communication channel                         content being requested from the
                                              requires federal agencies to publish a                                                                                                    grantees essentially remain same except
                                              60-day notice in the Federal Register                                      meets customer and partner priorities,
                                                                                                                         builds the Agency’s brands, and                                for the frequency of reporting. The other
                                              concerning each proposed collection of                                                                                                    sections of the document with reference
                                              information, including each proposed                                       contributes to the Agency’s health and
                                                                                                                         human services impact goals. Form                              to ‘‘quarterly’’ information will be
                                              extension or reinstatement of an existing                                                                                                 changed to reflect the shift from four-
                                              collection of information, before                                          Number: CMS–10415 (OMB control
                                                                                                                         number: 0938–1185); Frequency:                                 times a year reporting requirement to
                                              submitting the collection to OMB for                                                                                                      once per year and once at the end of the
                                              approval. To comply with this                                              Occasionally; Affected Public:
                                                                                                                         Individuals and Households, Business                           project period.
                                              requirement, CMS is publishing this
                                              notice.                                                                    or other for-profits and Not-for-profit                          Respondents: Tribal Government,
                                                                                                                         institutions, State, Local or Tribal                           Native non-profit organizations, Tribal
                                              Information Collection                                                     Governments; Number of Respondents:                            Colleges & Universities receiving ANA
                                                1. Type of Information Collection                                        1,000,000; Total Annual Responses:                             funding.
                                              Request: Extension of a currently                                          1,000,000; Total Annual Hours: 35,000.                         Annual Burden Estimates
                                              approved collection; Title of                                              (For policy questions regarding this
                                              Information Collection: Generic                                            collection contact John Booth at 410–                            The following is the hour of burden
                                              Clearance for the Collection Customer                                      786–6577.                                                      estimate for this information collection:

                                                                                                                                                                                        Number of           Average
                                                                                                                                                                       Number of                                          Total burden
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                Instrument                                                                            responses per       burden hours
                                                                                                                                                                      respondents                                            hours
                                                                                                                                                                                        respondent        per response

                                              ADR .................................................................................................................        275              2                  2               275




                                         VerDate Sep<11>2014         17:37 Oct 29, 2015         Jkt 238001      PO 00000        Frm 00040       Fmt 4703       Sfmt 4703   E:\FR\FM\30OCN1.SGM   30OCN1


                                              66906                         Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices

                                                Estimated Total Annual Burden                         liposome drug products submitted in                   2002–D–0093 (formerly docket ID
                                              Hours: 275.                                             new drug applications (NDAs),                         2002D–0337) for ‘‘Liposome Drug
                                                Additional Information: Copies of the                 abbreviated new drug applications                     Products: Chemistry, Manufacturing,
                                              proposed collection may be obtained by                  (ANDAs), and biologics license                        and Controls; Human Pharmacokinetics
                                              writing to the Administration for                       applications (BLAs) reviewed by the                   and Bioavailability; and Labeling
                                              Children and Families, Office of                        Center for Drug Evaluation and Research               Documentation.’’ Received comments
                                              Planning, Research and Evaluation, 370                  (CDER).                                               will be placed in the docket and, except
                                              L’Enfant Promenade SW., Washington,                     DATES: Although you can comment on                    for those submitted as ‘‘Confidential
                                              DC 20447, Attn: ACF Reports Clearance                   any guidance at any time (see 21 CFR                  Submissions,’’ publicly viewable at
                                              Officer. All requests should be                         10.115(g)(5)), to ensure that the Agency              http://www.regulations.gov or at the
                                              identified by the title of the information              considers your comment on this draft                  Division of Dockets Management
                                              collection. Email address:                              guidance before it begins work on the                 between 9 a.m. and 4 p.m., Monday
                                              infocollection@acf.hhs.gov.                             final version of the guidance, submit                 through Friday.
                                                OMB Comment: OMB is required to                       either electronic or written comments                    • Confidential Submissions—To
                                              make a decision concerning the                          on the draft guidance by December 29,                 submit a comment with confidential
                                              collection of information between 30                    2015.                                                 information that you do not wish to be
                                              and 60 days after publication of this                   ADDRESSES: You may submit comments                    made publicly available submit your
                                              document in the Federal Register.                       as follows:                                           comments only as a written/paper
                                              Therefore, a comment is best assured of                                                                       submission. You should submit two
                                              having its full effect if OMB receives it               Electronic Submissions                                copies total. One copy will include the
                                              within 30 days of publication. Written                    Submit electronic comments in the                   information you claim to be confidential
                                              comments and recommendations for the                    following way:                                        with a heading or cover note that states
                                              proposed information collection should                    • Federal eRulemaking Portal: http://               ‘‘THIS DOCUMENT CONTAINS
                                              be sent directly to the following: Office               www.regulations.gov. Follow the                       CONFIDENTIAL INFORMATION.’’ The
                                              of Management and Budget, Paperwork                     instructions for submitting comments.                 Agency will review this copy, including
                                              Reduction Project, Email: OIRA_                         Comments submitted electronically,                    the claimed confidential information, in
                                              SUBMISSION@OMB.EOP.GOV, Attn:                           including attachments, to http://                     its consideration of comments. The
                                              Desk Officer for the Administration for                 www.regulations.gov will be posted to                 second copy, which will have the
                                              Children and Families.                                  the docket unchanged. Because your                    claimed confidential information
                                                                                                      comment will be made public, you are                  redacted/blacked out, will be available
                                              Robert Sargis,                                          solely responsible for ensuring that your             for public viewing and posted on http://
                                              Reports Clearance Officer.                              comment does not include any                          www.regulations.gov. Submit both
                                              [FR Doc. 2015–27666 Filed 10–29–15; 8:45 am]            confidential information that you or a                copies to the Division of Dockets
                                              BILLING CODE 4184–01–P                                  third party may not wish to be posted,                Management. If you do not wish your
                                                                                                      such as medical information, your or                  name and contact information to be
                                                                                                      anyone else’s Social Security number, or              made publicly available, you can
                                              DEPARTMENT OF HEALTH AND                                confidential business information, such               provide this information on the cover
                                              HUMAN SERVICES                                          as a manufacturing process. Please note               sheet and not in the body of your
                                                                                                      that if you include your name, contact                comments and you must identify this
                                              Food and Drug Administration                            information, or other information that                information as ‘‘confidential.’’ Any
                                              [Docket No. FDA–2002–D–0093 (Formerly                   identifies you in the body of your                    information marked as ‘‘confidential’’
                                              Docket ID 2002D–0337)]                                  comments, that information will be                    will not be disclosed except in
                                                                                                      posted on http://www.regulations.gov.                 accordance with 21 CFR 10.20 and other
                                              Liposome Drug Products: Chemistry,                        • If you want to submit a comment                   applicable disclosure law. For more
                                              Manufacturing, and Controls; Human                      with confidential information that you                information about FDA’s posting of
                                              Pharmacokinetics and Bioavailability;                   do not wish to be made available to the               comments to public dockets, see 80 FR
                                              and Labeling Documentation; Draft                       public submit the comment as a written/               56469, September 18, 2015, or access
                                              Guidance for Industry; Availability                     paper submission and in the manner                    the information at: http://www.fda.gov/
                                                                                                      detailed (see ‘‘Written/Paper                         regulatoryinformation/dockets/
                                              AGENCY:    Food and Drug Administration,                Submissions’’ and ‘‘Instructions’’).                  default.htm.
                                              HHS.                                                                                                             Docket: For access to the docket to
                                              ACTION:   Notice of availability.                       Written/Paper Submissions                             read background documents or the
                                                                                                         Submit written/paper submissions as                electronic and written/paper comments
                                              SUMMARY:   The Food and Drug                            follows:                                              received, go to http://
                                              Administration (FDA) is announcing the                     • Mail/Hand delivery/Courier (for                  www.regulations.gov and insert the
                                              availability of a revised draft guidance                written/paper submissions): Division of               docket number, found in brackets in the
                                              for industry entitled ‘‘Liposome Drug                   Dockets Management (HFA–305), Food                    heading of this document, into the
                                              Products: Chemistry, Manufacturing,                     and Drug Administration, 5630 Fishers                 ‘‘Search’’ box and follow the prompts
                                              and Controls; Human Pharmacokinetics                    Lane, Rm. 1061, Rockville, MD 20852.                  and/or go to the Division of Dockets
                                              and Bioavailability; and Labeling                          • For written/paper comments                       Management, 5630 Fishers Lane, Rm.
                                              Documentation.’’ This revised draft                     submitted to the Division of Dockets                  1061, Rockville, MD 20852.
                                              guidance document replaces the draft of                 Management, FDA will post your                           Submit written requests for single
tkelley on DSK3SPTVN1PROD with NOTICES




                                              the same name that published on                         comment, as well as any attachments,                  copies of the draft guidance to the
                                              August 21, 2002. This revised draft                     except for information submitted,                     Division of Drug Information, Center for
                                              guidance provides recommendations to                    marked and identified, as confidential,               Drug Evaluation and Research, Food
                                              applicants on the chemistry,                            if submitted as detailed in                           and Drug Administration, 10001 New
                                              manufacturing, and controls (CMC);                      ‘‘Instructions.’’                                     Hampshire Ave., Hillandale Building,
                                              pharmacokinetics and bioavailability;                      Instructions: All submissions received             4th Floor, Silver Spring, MD 20993–
                                              and labeling documentation for                          must include the Docket No. FDA–                      0002. Send one self-addressed adhesive


                                         VerDate Sep<11>2014   17:37 Oct 29, 2015   Jkt 238001   PO 00000   Frm 00041   Fmt 4703   Sfmt 4703   E:\FR\FM\30OCN1.SGM   30OCN1



Document Created: 2015-12-14 15:29:06
Document Modified: 2015-12-14 15:29:06
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 Citation80 FR 66905 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR