80_FR_62736 80 FR 62536 - Submission for OMB Review; Comment Request

80 FR 62536 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 200 (October 16, 2015)

Page Range62536-62537
FR Document2015-26320

Federal Register, Volume 80 Issue 200 (Friday, October 16, 2015)
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62536-62537]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Native Language Preservation and Maintenance Grant 
Application Template Pilot (Funding Application Submission Tool 
(F.A.S.T. form))
    OMB No.:
    Description: The proposed F.A.S.T. form is intended to be used by 
applicants in the Administration for Native Americans' Native American 
Language Preservation and Maintenance grant competition in FY 2016. The 
F.A.S.T. form is proposed to be piloted as a consolidated and 
streamlined pre-formatted electronic application form that is user-
friendly and has an interactive interface providing structure and 
clarity for applicants. The proposed F.A.S.T. form is not intended to 
replace the Funding Opportunity Announcement (FOAs) which will still 
function as the full text of all funding opportunities for which 
applications are sought and considered by the Administration for Native 
Americans.
    The proposed F.A.S.T. form will be used in a pilot capacity in just 
one Administration for Native Americans' discretionary program areas: 
Native American Language Preservation and Maintenance. All applicants 
applying for funding in that program area will be required to use the 
F.A.S.T. form during the pilot competition proposed for FY16 unless 
they request and receive approval to submit a paper application. By 
using the F.A.S.T. form no applicant will be required to provide any 
information beyond what is already required by the FOA. Additionally, 
free training and technical assistance will be available to all 
applicants on use of the F.A.S.T. form.
    ANA intends to use the project proposals submitted via the F.A.S.T. 
form to make funding decisions for Native American Language 
Preservation and Maintenance grant awards made in the FY 2016 pilot 
year. In addition, ANA will solicit feedback from applicants and panel 
reviewers to obtain feedback on the results, outcomes, and their 
recommendations regarding the F.A.S.T. form as a user friendly method 
of applying for funding opportunities. If the pilot is successful in 
making it easier for applicants to apply, ANA will consider potentially 
expanding use of the F.A.S.T. form to all Administration for Native 
Americans' discretionary funding areas in subsequent years.
    Respondents: 40.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
F.A.S.T. form...............................              40               28              .50               14
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 560.

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: 
infocollection@acf.hhs.gov.

OMB Comment

    OMB is required to make a decision concerning the collection of 
information between 30 and 60 days after publication of this document 
in the Federal Register. Therefore, a comment is best assured of having 
its full effect if OMB receives it within 30 days of publication. 
Written comments and recommendations for the proposed information 
collection should be sent directly to the following: Office of 
Management and Budget, Paperwork Reduction Project, Email: 
OIRA_SUBMISSION@OMB.EOP.GOV,

[[Page 62537]]

Attn: Desk Officer for the Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-26320 Filed 10-15-15; 8:45 am]
 BILLING CODE 4184-01-P



                                                62536                                  Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices

                                                (OMB control number: 0938–0997);                                         the CMS–1490S (Patient’s Request for                         formatted electronic application form
                                                Frequency: On occasion; Affected                                         Medicare Payment) was explicitly                             that is user-friendly and has an
                                                Public: Private sector (Business or other                                developed for easy use by beneficiaries                      interactive interface providing structure
                                                for-profit and Not-for-profit                                            who file their own claims. The form can                      and clarity for applicants. The proposed
                                                institutions); Number of Respondents:                                    be obtained from any Social Security                         F.A.S.T. form is not intended to replace
                                                53,111; Total Annual Responses:                                          office or Medicare carrier. Form                             the Funding Opportunity
                                                181,909,654; Total Annual Hours:                                         Number: CMS–1500(08/05), CMS–1490–                           Announcement (FOAs) which will still
                                                1,567,455. (For policy questions                                         S (OMB control number: 0938–0999)                            function as the full text of all funding
                                                regarding this collection contact Matt                                   Frequency: On occasion; Affected                             opportunities for which applications are
                                                Klischer at 410–786–7488.)                                               Public: State, Local, or Tribal                              sought and considered by the
                                                   4. Type of Information Collection                                     Governments, Private sector (Business                        Administration for Native Americans.
                                                Request: Extension of a currently                                        or other-for-profit and Not-for-profit                          The proposed F.A.S.T. form will be
                                                approved collection; Title of                                            institutions); Number of Respondents:                        used in a pilot capacity in just one
                                                Information Collection: Health                                           1,448,346; Total Annual Responses:                           Administration for Native Americans’
                                                Insurance Common Claims Form and                                         988,005,045; Total Annual Hours:                             discretionary program areas: Native
                                                Supporting Regulations at 42 CFR part                                    21,418,336. (For policy questions                            American Language Preservation and
                                                424, Subpart C; Use: The Form CMS–                                       regarding this collection contact                            Maintenance. All applicants applying
                                                1500 answers the needs of many health                                    Shannon Seales at 410–786–4089.)                             for funding in that program area will be
                                                insurers. It is the basic form prescribed                                                                                             required to use the F.A.S.T. form during
                                                                                                                            Dated: October 13, 2015.
                                                by CMS for the Medicare program for                                                                                                   the pilot competition proposed for FY16
                                                claims from physicians and suppliers.                                    William N. Parham, III,
                                                                                                                         Director, Paperwork Reduction Staff, Office                  unless they request and receive
                                                The Medicaid State Agencies,                                                                                                          approval to submit a paper application.
                                                CHAMPUS/TriCare, Blue Cross/Blue                                         of Strategic Operations and Regulatory
                                                                                                                         Affairs.                                                     By using the F.A.S.T. form no applicant
                                                Shield Plans, the Federal Employees
                                                                                                                         [FR Doc. 2015–26390 Filed 10–15–15; 8:45 am]                 will be required to provide any
                                                Health Benefit Plan, and several private
                                                                                                                                                                                      information beyond what is already
                                                health plans also use it; it is the de facto                             BILLING CODE 4120–01–P
                                                                                                                                                                                      required by the FOA. Additionally, free
                                                standard ‘‘professional’’ claim form.
                                                   Medicare carriers use the data                                                                                                     training and technical assistance will be
                                                collected on the CMS–1500 and the                                        DEPARTMENT OF HEALTH AND                                     available to all applicants on use of the
                                                CMS–1490S to determine the proper                                        HUMAN SERVICES                                               F.A.S.T. form.
                                                amount of reimbursement for Part B                                                                                                       ANA intends to use the project
                                                medical and other health services (as                                    Administration for Children and                              proposals submitted via the F.A.S.T.
                                                listed in section 1861(s) of the Social                                  Families                                                     form to make funding decisions for
                                                Security Act) provided by physicians                                                                                                  Native American Language Preservation
                                                                                                                         Submission for OMB Review;                                   and Maintenance grant awards made in
                                                and suppliers to beneficiaries. The                                      Comment Request
                                                CMS–1500 is submitted by physicians/                                                                                                  the FY 2016 pilot year. In addition,
                                                suppliers for all Part B Medicare.                                         Title: Native Language Preservation                        ANA will solicit feedback from
                                                Serving as a common claim form, the                                      and Maintenance Grant Application                            applicants and panel reviewers to obtain
                                                CMS–1500 can be used by other third-                                     Template Pilot (Funding Application                          feedback on the results, outcomes, and
                                                party payers (commercial and nonprofit                                   Submission Tool (F.A.S.T. form))                             their recommendations regarding the
                                                health insurers) and other Federal                                         OMB No.:                                                   F.A.S.T. form as a user friendly method
                                                programs (e.g., CHAMPUS/TriCare,                                           Description: The proposed F.A.S.T.                         of applying for funding opportunities. If
                                                Railroad Retirement Board (RRB), and                                     form is intended to be used by                               the pilot is successful in making it
                                                Medicaid). However, as the CMS–1500                                      applicants in the Administration for                         easier for applicants to apply, ANA will
                                                displays data items required for other                                   Native Americans’ Native American                            consider potentially expanding use of
                                                third-party payers in addition to                                        Language Preservation and Maintenance                        the F.A.S.T. form to all Administration
                                                Medicare, the form is considered too                                     grant competition in FY 2016. The                            for Native Americans’ discretionary
                                                complex for use by beneficiaries when                                    F.A.S.T. form is proposed to be piloted                      funding areas in subsequent years.
                                                they file their own claims. Therefore,                                   as a consolidated and streamlined pre-                          Respondents: 40.

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

                                                F.A.S.T. form ...................................................................................................        40               28                .50            14



                                                 Estimated Total Annual Burden                                           Attn: ACF Reports Clearance Officer. All                     Federal Register. Therefore, a comment
                                                Hours: 560.                                                              requests should be identified by the title                   is best assured of having its full effect
                                                                                                                         of the information collection. Email                         if OMB receives it within 30 days of
srobinson on DSK5SPTVN1PROD with NOTICES




                                                Additional Information
                                                                                                                         address: infocollection@acf.hhs.gov.                         publication. Written comments and
                                                  Copies of the proposed collection may                                                                                               recommendations for the proposed
                                                                                                                         OMB Comment
                                                be obtained by writing to the                                                                                                         information collection should be sent
                                                Administration for Children and                                            OMB is required to make a decision                         directly to the following: Office of
                                                Families, Office of Planning, Research                                   concerning the collection of information                     Management and Budget, Paperwork
                                                and Evaluation, 370 L’Enfant                                             between 30 and 60 days after                                 Reduction Project, Email:
                                                Promenade SW., Washington, DC 20447,                                     publication of this document in the                          OIRA_SUBMISSION@OMB.EOP.GOV,


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                                                                              Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices                                        62537

                                                Attn: Desk Officer for the                              www.regulations.gov will be posted to                 Agency will review this copy, including
                                                Administration for Children and                         the docket unchanged. Because your                    the claimed confidential information, in
                                                Families.                                               comment will be made public, you are                  its consideration of comments. The
                                                                                                        solely responsible for ensuring that your             second copy, which will have the
                                                Robert Sargis,
                                                                                                        comment does not include any                          claimed confidential information
                                                Reports Clearance Officer.                              confidential information that you or a                redacted/blacked out, will be available
                                                [FR Doc. 2015–26320 Filed 10–15–15; 8:45 am]            third party may not wish to be posted,                for public viewing and posted on
                                                BILLING CODE 4184–01–P                                  such as medical information, your or                  http://www.regulations.gov. Submit
                                                                                                        anyone else’s Social Security number, or              both copies to the Division of Dockets
                                                                                                        confidential business information, such               Management. If you do not wish your
                                                DEPARTMENT OF HEALTH AND                                as a manufacturing process. Please note               name and contact information to be
                                                HUMAN SERVICES                                          that if you include your name, contact                made publicly available, you can
                                                                                                        information, or other information that                provide this information on the cover
                                                Food and Drug Administration                            identifies you in the body of your                    sheet and not in the body of your
                                                [Docket No. FDA–2015–D–3474]                            comments, that information will be                    comments and you must identify this
                                                                                                        posted on http://www.regulations.gov.                 information as ‘‘confidential.’’ Any
                                                Draft Recommendations for the                             • If you want to submit a comment                   information marked as ‘‘confidential’’
                                                Permitted Daily Exposures for Two                       with confidential information that you                will not be disclosed except in
                                                Solvents, Triethylamine and                             do not wish to be made available to the               accordance with 21 CFR 10.20 and other
                                                Methylisobutylketone, According to                      public, submit the comment as a                       applicable disclosure law. For more
                                                the Maintenance Procedures for the                      written/paper submission and in the                   information about FDA’s posting of
                                                Guidance Q3C Impurities: Residual                       manner detailed (see ‘‘Written/Paper                  comments to public dockets, see 80 FR
                                                Solvents; International Conference on                   Submissions’’ and ‘‘Instructions’’).                  56469, September 18, 2015, or access
                                                Harmonisation; Availability                                                                                   the information at: http://www.fda.gov/
                                                                                                        Written/Paper Submissions
                                                AGENCY:    Food and Drug Administration,                                                                      regulatoryinformation/dockets/
                                                                                                           Submit written/paper submissions as
                                                HHS.                                                                                                          default.htm.
                                                                                                        follows:
                                                ACTION:   Notice.                                          • Mail/Hand delivery/Courier (for                     Docket: For access to the docket to
                                                                                                        written/paper submissions): Division of               read background documents or the
                                                SUMMARY:   The Food and Drug                                                                                  electronic and written/paper comments
                                                                                                        Dockets Management (HFA–305), Food
                                                Administration (FDA or Agency) is                                                                             received, go to http://
                                                                                                        and Drug Administration, 5630 Fishers
                                                announcing the availability of draft                                                                          www.regulations.gov and insert the
                                                                                                        Lane, Rm. 1061, Rockville, MD 20852.
                                                recommendations for a new permitted                        • For written/paper comments                       docket number, found in brackets in the
                                                daily exposure (PDE) for the residual                   submitted to the Division of Dockets                  heading of this document, into the
                                                solvent triethylamine and a revised PDE                 Management, FDA will post your                        ‘‘Search’’ box and follow the prompts
                                                for the residual solvent                                comment, as well as any attachments,                  and/or go to the Division of Dockets
                                                methylisobutylketone, according to the                  except for information submitted,                     Management, 5630 Fishers Lane, Rm.
                                                maintenance procedures for the                          marked and identified, as confidential,               1061, Rockville, MD 20852.
                                                guidance for industry entitled ‘‘Q3C                    if submitted as detailed in                              Submit written requests for single
                                                Impurities: Residual Solvents.’’ The                    ‘‘Instructions.’’                                     copies of the draft recommendations to
                                                draft recommendations were prepared                        Instructions: All submissions received             the Division of Drug Information (HFD–
                                                under the auspices of the International                 must include the Docket No. FDA–                      240), Center for Drug Evaluation and
                                                Conference on Harmonisation of                          2015–D–3474 for ‘‘Draft                               Research (CDER), Food and Drug
                                                Technical Requirements for Registration                 Recommendations for the Permitted                     Administration, 10001 New Hampshire
                                                of Pharmaceuticals for Human Use                        Daily Exposures for Two Solvents,                     Ave., Hillandale Building, 4th Floor,
                                                (ICH). The document is intended to                      Triethylamine and                                     Silver Spring, MD 20993–0002, or the
                                                recommend acceptable amounts for the                    Methylisobutylketone, According to the                Office of Communication, Outreach and
                                                listed residual solvents in                             Maintenance Procedures for the                        Development, Center for Biologics
                                                pharmaceuticals for the safety of the                   Guidance Q3C Impurities: Residual                     Evaluation and Research (CBER), Food
                                                patient.                                                Solvents; International Conference on                 and Drug Administration, 10903 New
                                                DATES: Although you can comment on                      Harmonisation; Availability.’’ Received               Hampshire Ave., Bldg. 71, Rm. 3128,
                                                any guidance at any time (see 21 CFR                    comments will be placed in the docket                 Silver Spring, MD 20993–0002. Send
                                                10.115(g)(5)), to ensure that the Agency                and, except for those submitted as                    one self-addressed adhesive label to
                                                considers your comment on the draft                     ‘‘Confidential Submissions,’’ publicly                assist the office in processing your
                                                recommendations before it begins work                   viewable at http://www.regulations.gov                requests. The draft recommendations
                                                on the final recommendations, submit                    or at the Division of Dockets                         may also be obtained by mail by calling
                                                either electronic or written comments                   Management between 9 a.m. and 4 p.m.,                 CBER at 1–800–835–4709 or 240–402–
                                                on the document by December 15, 2015.                   Monday through Friday.                                8010. See the SUPPLEMENTARY
                                                ADDRESSES: You may submit comments                         • Confidential Submissions—To                      INFORMATION section for electronic
                                                as follows:                                             submit a comment with confidential                    access to the draft recommendations.
                                                                                                        information that you do not wish to be                FOR FURTHER INFORMATION CONTACT:
                                                Electronic Submissions                                  made publicly available, submit your                  Regarding the guidance: Timothy J.
srobinson on DSK5SPTVN1PROD with NOTICES




                                                  Submit electronic comments in the                     comments only as a written/paper                      McGovern, Center for Drug Evaluation
                                                following way:                                          submission. You should submit two                     and Research, Food and Drug
                                                  • Federal eRulemaking Portal: http://                 copies total. One copy will include the               Administration, 10903 New Hampshire
                                                www.regulations.gov. Follow the                         information you claim to be confidential              Ave., Bldg. 22, Rm. 6300, Silver Spring,
                                                instructions for submitting comments.                   with a heading or cover note that states              MD 20993–0002, 240–402–0477.
                                                Comments submitted electronically,                      ‘‘THIS DOCUMENT CONTAINS                                 Regarding the ICH: Michelle Limoli,
                                                including attachments, to http://                       CONFIDENTIAL INFORMATION.’’ The                       CBER International Programs, Food and


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Document Created: 2015-12-14 15:23:23
Document Modified: 2015-12-14 15:23:23
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 62536 

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