81_FR_95390 81 FR 95142 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

81 FR 95142 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range95142-95143
FR Document2016-31184

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016)
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Notices]
[Pages 95142-95143]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31184]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Disease, Disability, and Injury Prevention and Control Special 
Emphasis Panel (SEP): Initial Review

    In accordance with Section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces a meeting for the initial review of 
applications in response to Funding Opportunity Announcement (FOA) 
GH17-001, Evaluations to Improve Prevention Interventions Under the 
President's Emergency Plan for AIDS Relief (PEPFAR).
    Time and Date: 9:00 a.m.-2:00 p.m., EST, January 25, 2017 (Closed).
    Place: Teleconference.
    Status: The meeting will be closed to the public in accordance with 
provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and 
the Determination of the Director, Management Analysis and Services 
Office, CDC, pursuant to Public Law 92-463.
    Matters for Discussion: The meeting will include the initial 
review, discussion, and evaluation of applications received in response 
to FOA GH17-001, Evaluations to Improve Prevention Interventions Under 
the President's Emergency Plan for AIDS Relief (PEPFAR).
    Contact Person for More Information: Hylan Shoob, Scientific Review 
Officer, Center for Global Health (CGH) Science Office, CGH, CDC, 1600 
Clifton Road, NE., Mailstop D-69, Atlanta, Georgia 30329, Telephone: 
(404) 639-4796.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both the Centers for Disease Control and

[[Page 95143]]

Prevention and the Agency for Toxic Substances and Disease Registry.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2016-31184 Filed 12-23-16; 8:45 am]
 BILLING CODE 4163-18-P



                                                    95142                      Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices

                                                    Washington, DC 20405. ATTN: Ms.                         applies to the proposed rule. The other               1800 F Street NW., Washington, DC
                                                    Flowers/IC 9000–0196.                                   respondent believed that the estimate of              20405, telephone 202–501–4755. Please
                                                       Instructions: Please submit comments                 reporting time of only two hours per                  cite OMB Control Number 9000–0196,
                                                    only and cite IC 9000–0196, in all                      respondent is grossly underestimated.                 Payment of Subcontractors, in all
                                                    correspondence related to this case. All                This negligible amount of time assumes                correspondence.
                                                    comments received will be posted                        that all contractors can easily identify                Dated: November 15, 2016.
                                                    without change to http://                               from their payment systems which                      Lorin S. Curit,
                                                    www.regulations.gov, including any                      subcontractors are small businesses. The
                                                                                                                                                                  Director, Federal Acquisition Policy Division,
                                                    personal and/or business confidential                   respondent believed that this is often                Office of Governmentwide Acquisition Policy,
                                                    information provided. To confirm                        not the case, and that the small business             Office of Acquisition Policy, Office of
                                                    receipt of your comment(s), please                      size status of a subcontractor may be                 Governmentwide Policy.
                                                    check www.regulations.gov,                              unknown to the contractor’s other                     [FR Doc. 2016–31130 Filed 12–23–16; 8:45 am]
                                                    approximately two to three days after                   accounting systems. The other                         BILLING CODE 6820–EP–P
                                                    submission to verify posting (except                    respondent commented that since the
                                                    allow 30 days for posting of comments                   Small Business Jobs Act of 2010 does
                                                    submitted by mail).                                     not specifically require that the
                                                    FOR FURTHER INFORMATION CONTACT: Mr.                    subcontractor payment clause apply to                 DEPARTMENT OF HEALTH AND
                                                    Curtis E. Glover, Sr., Procurement                      commercial contracts, the respondent                  HUMAN SERVICES
                                                    Analyst, at 202–501–1448, or email                      recommended that the FAR Council
                                                    curtis.glover@gsa.gov.                                  seek additional information about the                 Centers for Disease Control and
                                                                                                            burden on contractors before a                        Prevention
                                                    SUPPLEMENTARY INFORMATION:
                                                                                                            determination is made to apply the
                                                    A. Purpose                                              payment of subcontractor requirements                 Disease, Disability, and Injury
                                                                                                            to commercial item acquisitions. The                  Prevention and Control Special
                                                       Section 1334 of the Small Business                                                                         Emphasis Panel (SEP): Initial Review
                                                    Jobs and Credit Act of 2010 (Pub. L.                    respondent did not find that the
                                                    111–240) and the Small Business                         availability of limited information                     In accordance with Section 10(a)(2) of
                                                    Administration’s Final Rule at 78 FR                    indicated that the burden may not be                  the Federal Advisory Committee Act
                                                    42391, Small Business Subcontracting,                   significant, as described in the proposed             (Pub. L. 92–463), the Centers for Disease
                                                    published on July 16, 2013, and                         rule. Rather, initial feedback from                   Control and Prevention (CDC)
                                                    effective August 15, 2013, requires the                 contractors suggested that the burdens                announces a meeting for the initial
                                                    prime contractor to self-report to the                  associated with reporting under the rule              review of applications in response to
                                                    contracting officer when the prime                      will have a significant impact.                       Funding Opportunity Announcement
                                                    contractor makes late or reduced                           Response: The respondents do not                   (FOA) GH17–001, Evaluations to
                                                    payments to small business                              offer data with which to support                      Improve Prevention Interventions Under
                                                    subcontractors. In addition, the                        changing the current estimated public                 the President’s Emergency Plan for
                                                    contracting officer is required to record               burden hours. However, since this is a                AIDS Relief (PEPFAR).
                                                    the identity of contractors with a history              new rule without an empirical frame of                  Time and Date: 9:00 a.m.–2:00 p.m.,
                                                    of late or reduced payments to small                    reference, the public reporting burden is             EST, January 25, 2017 (Closed).
                                                    business subcontractors in the Federal                  reviewed every three years and can be                   Place: Teleconference.
                                                    Awardee Performance and Integrity                       adjusted as necessary.                                  Status: The meeting will be closed to
                                                                                                               Public comments are particularly                   the public in accordance with
                                                    Information System (FAPIIS). FAR Part
                                                                                                            invited on: Whether this collection of                provisions set forth in Section
                                                    42 is revised to include in the past
                                                                                                            information is necessary for the proper               552b(c)(4) and (6), Title 5 U.S.C., and
                                                    performance evaluation reduced or
                                                                                                            performance of functions of the FAR,                  the Determination of the Director,
                                                    untimely payments reported to the
                                                                                                            and whether it will have practical                    Management Analysis and Services
                                                    contracting officer by the prime
                                                                                                            utility; whether our estimate of the                  Office, CDC, pursuant to Public Law 92–
                                                    contractor in accordance with the clause
                                                                                                            public burden of this collection of                   463.
                                                    at 52.242–XX, Payments to Small
                                                                                                            information is accurate, and based on                   Matters for Discussion: The meeting
                                                    Business Subcontractors, that are
                                                                                                            valid assumptions and methodology;                    will include the initial review,
                                                    determined by the contracting officer to
                                                                                                            ways to enhance the quality, utility, and             discussion, and evaluation of
                                                    be unjustified.
                                                                                                            clarity of the information to be                      applications received in response to
                                                       A notice was published in the Federal
                                                                                                            collected; and ways in which we can                   FOA GH17–001, Evaluations to Improve
                                                    Register at 81 FR 3087, on January 20,
                                                                                                            minimize the burden of the collection of              Prevention Interventions Under the
                                                    2016, as part of a proposed rule under
                                                                                                            information on those who are to                       President’s Emergency Plan for AIDS
                                                    FAR Case 2014–004. Two comments
                                                                                                            respond, through the use of appropriate               Relief (PEPFAR).
                                                    were received on the information
                                                                                                            technological collection techniques or                  Contact Person for More Information:
                                                    collection.
                                                                                                            other forms of information technology.                Hylan Shoob, Scientific Review Officer,
                                                    B. Discussion and Analysis                                                                                    Center for Global Health (CGH) Science
                                                                                                            C. Annual Reporting Burden
                                                       Comment: Two respondents stated                        Respondents: 5,457.                                 Office, CGH, CDC, 1600 Clifton Road,
                                                    that the Councils had underestimated                                                                          NE., Mailstop D–69, Atlanta, Georgia
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                                                                                                              Responses per Respondent: 1.
                                                    the public burden in regards to the                       Total Annual Responses: 5,457.                      30329, Telephone: (404) 639–4796.
                                                    proposed rule. One respondent                             Hours per Response: 2.                                The Director, Management Analysis
                                                    commented that the FAR Council has                        Total Burden Hours: 10,914.                         and Services Office, has been delegated
                                                    greatly underestimated the                                Obtaining Copies of Proposals:                      the authority to sign Federal Register
                                                    implementation burden on commercial                     Requesters may obtain a copy of the                   notices pertaining to announcements of
                                                    item and COTS item contractors,                         information collection documents from                 meetings and other committee
                                                    especially considering the broad                        the General Services Administration,                  management activities, for both the
                                                    definition of ‘‘subcontractor’’ that                    Regulatory Secretariat Division (MVCB),               Centers for Disease Control and


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                                                                               Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Notices                                          95143

                                                    Prevention and the Agency for Toxic                     Resettlement, 330 C Street SW.,                       SUMMARY:    The Food and Drug
                                                    Substances and Disease Registry.                        Washington, DC 20201. Email:                          Administration (FDA or Agency) is
                                                                                                            DCSProgram@acf.hhs.gov.                               announcing the availability of the
                                                    Elaine L. Baker,
                                                                                                            SUPPLEMENTARY INFORMATION: ORR is                     guidance entitled ‘‘Factors to Consider
                                                    Director, Management Analysis and Services                                                                    Regarding Benefit-Risk in Medical
                                                    Office, Centers for Disease Control and                 continuously monitoring its capacity to
                                                    Prevention.                                             provide post-release services to the                  Device Product Availability,
                                                                                                            unaccompanied children in HHS                         Compliance, and Enforcement
                                                    [FR Doc. 2016–31184 Filed 12–23–16; 8:45 am]
                                                                                                            custody.                                              Decisions.’’ This guidance is intended to
                                                    BILLING CODE 4163–18–P
                                                                                                               ORR has specific requirements for the              provide clarity for FDA staff and
                                                                                                            provision of services. Award recipients               industry regarding the benefit and risk
                                                    DEPARTMENT OF HEALTH AND                                must have the infrastructure, licensing,              factors FDA may consider in prioritizing
                                                    HUMAN SERVICES                                          experience, and appropriate level of                  resources for compliance and
                                                                                                            trained staff to meet those requirements.             enforcement efforts to maximize
                                                    Administration for Children and                         The expansion of the existing post-                   medical device quality and patient
                                                    Families                                                release services program through this                 safety. Although product availability
                                                                                                            supplemental award is a key strategy for              and other medical device compliance
                                                    [CFDA Number: 93.676]                                                                                         and enforcement decisions are generally
                                                                                                            ORR to be prepared to meet its
                                                                                                            responsibility of safe and timely release             fact-specific, FDA believes that
                                                    Announcing the Intent To Award a
                                                                                                            of Unaccompanied Children referred to                 explaining how we consider the factors
                                                    Single-Source Program Expansion
                                                                                                            its care by DHS and so that the US                    listed in the guidance will improve the
                                                    Supplements to Cooperative
                                                                                                            Border Patrol can continue its vital                  consistency and transparency of these
                                                    Agreements Within the Office of
                                                                                                            national security mission to prevent                  kinds of decisions. A common
                                                    Refugee Resettlement’s
                                                                                                            illegal migration, trafficking, and protect           understanding of how FDA considers
                                                    Unaccompanied Children’s (UC)
                                                                                                            the borders of the United States.                     benefit and risk may better align
                                                    Program
                                                                                                               Statutory Authority: This program is
                                                                                                                                                                  industry’s and FDA’s focus on actions
                                                    AGENCY:   Office of Refugee Resettlement,               authorized by—                                        that maximize benefit to patients,
                                                    ACF, HHS.                                                  (A) Section 462 of the Homeland Security           improve medical device quality, and
                                                    ACTION: This notice announces the                       Act of 2002, which in March 2003,                     reduce risk to patients. This guidance is
                                                    intent to award a single-source                         transferred responsibility for the care and           in effect at this time.
                                                    expansion supplement grant to existing                  custody of Unaccompanied Alien Children               DATES: Submit either electronic or
                                                    grantees’, BCFS Health and Human                        from the Commissioner of the former                   written comments on this guidance at
                                                                                                            Immigration and Naturalization Service (INS)
                                                    Services (90ZU0075) and the U.S.                                                                              any time. General comments on Agency
                                                                                                            to the Director of ORR of the Department of
                                                    Committee for Refugees and Immigrants                   Health and Human Services (HHS).                      guidance documents are welcome at any
                                                    (90ZU0081), Cooperative Agreement                          (B) The Flores Settlement Agreement, Case          time.
                                                    within the Office of Refugee                            No. CV85–4544RJK (C.D. Cal. 1996), as well            ADDRESSES: You may submit comments
                                                    Resettlement’s Unaccompanied                            as the William Wilberforce Trafficking                as follows:
                                                    Children’s (UC) Program.                                Victims Protection Reauthorization Act of
                                                                                                            2008 (Pub. L. 110–457), which authorizes              Electronic Submissions
                                                    SUMMARY:    The Administration for                      post release services under certain conditions          Submit electronic comments in the
                                                    Children and Families (ACF), Office of                  to eligible children. All programs must               following way:
                                                    Refugee Resettlement (ORR), announces                   comply with the Flores Settlement
                                                                                                            Agreement, Case No. CV85–4544–RJK (C.D.
                                                                                                                                                                    • Federal eRulemaking Portal:
                                                    its intent to award a cooperative                                                                             https://www.regulations.gov. Follow the
                                                    agreement of up to $3,311,087 as a                      Cal. 1996), pertinent regulations and ORR
                                                                                                            policies and procedures.                              instructions for submitting comments.
                                                    single-source expansion supplements to                                                                        Comments submitted electronically,
                                                    the Post Release Services Programs                      Christopher Beach,                                    including attachments, to https://
                                                    within the Unaccompanied Children’s                     Senior Grants Policy Specialist, Division of          www.regulations.gov will be posted to
                                                    (UC) Program.                                           Grants Policy, Office of Administration,              the docket unchanged. Because your
                                                       The expansion supplement grants will                 Administration for Children and Families.             comment will be made public, you are
                                                    support the immediate need for                          [FR Doc. 2016–31062 Filed 12–23–16; 8:45 am]          solely responsible for ensuring that your
                                                    additional post-release services to                     BILLING CODE 4184–45–P                                comment does not include any
                                                    accommodate the increasing number of                                                                          confidential information that you or a
                                                    UCs being referred by DHS, and as a                                                                           third party may not wish to be posted,
                                                    result, the increase of UCs referred for                DEPARTMENT OF HEALTH AND                              such as medical information, your or
                                                    post-release services. The increase in                  HUMAN SERVICES                                        anyone else’s Social Security number, or
                                                    the UC population necessitates the need                                                                       confidential business information, such
                                                    for expansion of services to expedite the               Food and Drug Administration
                                                                                                                                                                  as a manufacturing process. Please note
                                                    release of UC. The Flores v. Reno                       [Docket No. FDA–2016–D–1495]                          that if you include your name, contact
                                                    settlement agreement requires that                                                                            information, or other information that
                                                    requires the timely release of children                 Factors to Consider Regarding Benefit-                identifies you in the body of your
                                                    and youth to qualified parents,                         Risk in Medical Device Product                        comments, that information will be
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    guardians, relatives or other adults,                   Availability, Compliance, and                         posted on https://www.regulations.gov.
                                                    referred to as ‘‘sponsors.’’                            Enforcement Decisions; Guidance for                     • If you want to submit a comment
                                                    DATES: Supplemental award funds will                    Industry and Food and Drug                            with confidential information that you
                                                    support activities from September 30,                   Administration Staff; Availability                    do not wish to be made available to the
                                                    2015 through September 29, 2016.                                                                              public, submit the comment as a
                                                                                                            AGENCY:    Food and Drug Administration,
                                                    FOR FURTHER INFORMATION CONTACT:                        HHS.                                                  written/paper submission and in the
                                                    Jallyn Sualog, Director, Division of                                                                          manner detailed (see ‘‘Written/Paper
                                                                                                            ACTION:   Notice of availability.
                                                    Children’s Services, Office of Refugee                                                                        Submissions’’ and ‘‘Instructions’’).


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Document Created: 2018-02-14 09:13:23
Document Modified: 2018-02-14 09:13:23
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
Dates9:00 a.m.-2:00 p.m., EST, January 25, 2017 (Closed).
FR Citation81 FR 95142 

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