80_FR_31489 80 FR 31384 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

80 FR 31384 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 105 (June 2, 2015)

Page Range31384-31385
FR Document2015-13331

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 105 (Tuesday, June 2, 2015)
[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31384-31385]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Prescription Drug Marketing Act of 
1987; Policies, Requirements, and Administrative Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing

[[Page 31385]]

that a collection of information entitled ``Prescription Drug Marketing 
Act of 1987; Policies, Requirements, and Administrative Procedures'' 
has been approved by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On March 06, 2015, the Agency submitted a 
proposed collection of information entitled ``Prescription Drug 
Marketing Act of 1987; Policies, Requirements, and Administrative 
Procedures'' to OMB for review and clearance under 44 U.S.C. 3507. An 
Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0435. The approval 
expires on May 31, 2018. A copy of the supporting statement for this 
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13331 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                    31384                           Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices

                                                    Secretary, HHS, summarizing the results                 Program Expansion for Acute                            DATES:   The period of support under
                                                    of completed dose reconstruction                        Respiratory Illness Surveillance                       these supplements is June 01, 2015
                                                    reviews.                                                Financed Solely by 2015 Prevention and                 through September 29, 2015.
                                                      The agenda is subject to change as                    Public Health Funds’’, IP–11–                          FOR FURTHER INFORMATION CONTACT:
                                                    priorities dictate.                                     00100501PPHF15.                                        Maggie Wynne, Director, Division of
                                                    CONTACT PERSON FOR MORE INFORMATION:                      Contact Person for More Information:                 Anti-Trafficking in Persons, Office of
                                                    Theodore Katz, Designated Federal                       Gregory Anderson, M.S., M.P.H.,                        Refugee Resettlement, 901 D Street SW.,
                                                    Officer, NIOSH, CDC, 1600 Clifton                       Scientific Review Officer, CDC, 1600                   Washington, DC 20024, Telephone (202)
                                                    Road, Mailstop E–20, Atlanta GA 30333,                  Clifton Road NE., Mailstop E60, Atlanta,               401–4664. Email: maggie.wynne@
                                                    Telephone (513)533–6800, Toll Free                      Georgia 30333, Telephone: (404) 718–                   acf.hhs.gov.
                                                    1(800) CDC–INFO, Email ocas@cdc.gov.                    8833.                                                  SUPPLEMENTARY INFORMATION: The
                                                      The Director, Management Analysis                       The Director, Management Analysis                    National Human Trafficking Victim
                                                    and Services Office, has been delegated                 and Services Office, has been delegated                Assistance Program (NHTVAP) provides
                                                    the authority to sign Federal Register                  the authority to sign Federal Register                 funding for comprehensive case
                                                    notices pertaining to announcements of                  notices pertaining to announcements of                 management services to victims of
                                                    meetings and other committee                            meetings and other committee                           trafficking and certain family members
                                                    management activities, for both the                     management activities, for both the                    on a per capita basis. The NHTVAP
                                                    Centers for Disease Control and                         Centers for Disease Control and                        grantees help clients gain access to
                                                    Prevention and the Agency for Toxic                     Prevention and the Agency for Toxic                    housing, employability services, mental
                                                    Substances and Disease Registry.                        Substances and Disease Registry.                       health screening and therapy, medical
                                                    Elaine L. Baker,                                        Elaine L. Baker,                                       care, and some legal services. During FY
                                                    Director, Management Analysis and Services                                                                     2015, a grantee, U.S. Committee for
                                                                                                            Director, Management Analysis and Services
                                                    Office, Centers for Disease Control and                 Office, Centers for Disease Control and                Refugees and Immigrants (USCRI),
                                                    Prevention.                                             Prevention.                                            served more clients than it had planned
                                                    [FR Doc. 2015–13311 Filed 6–1–15; 8:45 am]              [FR Doc. 2015–13315 Filed 6–1–15; 8:45 am]
                                                                                                                                                                   for in its budget for the year. Without
                                                    BILLING CODE 4163–19–P                                                                                         the additional funding, USCRI would
                                                                                                            BILLING CODE 4163–18–P
                                                                                                                                                                   have to make significant cuts in services
                                                                                                                                                                   to current clients and limit the
                                                    DEPARTMENT OF HEALTH AND                                DEPARTMENT OF HEALTH AND                               enrollment of new clients. Also, without
                                                    HUMAN SERVICES                                          HUMAN SERVICES                                         additional funding USCRI would not
                                                                                                                                                                   have sufficient programmatic support
                                                    Centers for Disease Control and                         Administration for Children and                        for the increase in client enrollments.
                                                    Prevention                                              Families                                               With the supplemental funding, USCRI
                                                                                                                                                                   will be able to ensure that all of the
                                                    Disease, Disability, and Injury                                                                                clients’ essential needs will be met.
                                                    Prevention and Control Special                          [CFDA Number: 93.598]
                                                                                                                                                                      Statutory Authority: Trafficking Victims
                                                    Emphasis Panel (SEP): Initial Review
                                                                                                            Announcement of the Award of a                         Protection Act of 2000 (TVPA), as amended,
                                                       In accordance with section 10(a)(2) of               Single-Source Program Expansion                        Section 107(b)(1)(B), 22 U.S.C. 7105(b)(1)(B),
                                                                                                            Supplement Grant to the U.S.                           authorizes funding for benefits and services
                                                    the Federal Advisory Committee Act                                                                             to foreign victims of severe forms of
                                                    (Pub. L. 92–463), the Centers for Disease               Committee for Refugees and                             trafficking in persons in the United States,
                                                    Control and Prevention (CDC)                            Immigrants in Arlington, VA                            potential victims of trafficking seeking HHS
                                                    announces a meeting for the initial                                                                            Certification, and certain family members.
                                                    review of applications in response to                   AGENCY:   Office of Refugee Resettlement,
                                                    Funding Opportunity Announcement                        ACF, HHS.                                              Christopher Beach,
                                                    (FOA), IP–11–00100501PPHF15, PPHF–                      ACTION: Announcement of the award of                   Senior Grants Policy Specialist, Office of
                                                                                                            a single-source program expansion                      Administration.
                                                    2015—Enhanced Surveillance for New
                                                                                                            supplement to the U.S. Committee for                   [FR Doc. 2015–13177 Filed 6–1–15; 8:45 am]
                                                    Vaccine Preventable Disease—A
                                                    Program Expansion for Acute                             Refugees and Immigrants (USCRI) to                     BILLING CODE 4184–47–P

                                                    Respiratory Illness Surveillance                        support expanded services to foreign
                                                    Financed Solely by 2015 Prevention and                  trafficking victims, potential trafficking
                                                                                                            victims, and certain family members.                   DEPARTMENT OF HEALTH AND
                                                    Public Health Funds.
                                                       Time and Date: 10:00 a.m.–3:00 p.m.,                                                                        HUMAN SERVICES
                                                    June 23, 2015 (Closed).                                 SUMMARY:   The Administration for
                                                                                                            Children and Families (ACF), Office of                 Food and Drug Administration
                                                       Place: Teleconference.
                                                       Status: The meeting will be closed to                Refugee Resettlement (ORR) announces                   [Docket No. FDA–2011–N–0279]
                                                    the public in accordance with                           the award of a single-source program
                                                    provisions set forth in section 552b(c)(4)              expansion supplement grant to U.S.                     Agency Information Collection
                                                    and (6), Title 5 U.S.C., and the                        Committee for Refugees and Immigrants                  Activities; Announcement of Office of
                                                    Determination of the Director,                          in Arlington, Virginia for a total of                  Management and Budget Approval;
                                                    Management Analysis and Services                        $1,060,805.                                            Prescription Drug Marketing Act of
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Office, CDC, pursuant to Public Law 92–                   The supplemental funding will ensure                 1987; Policies, Requirements, and
                                                    463.                                                    that clients’ essential needs, such as                 Administrative Procedures
                                                       Matters for Discussion: The meeting                  housing, transportation,                               AGENCY:   Food and Drug Administration,
                                                    will include the initial review,                        communication, food, and medical care,                 HHS.
                                                    discussion, and evaluation of                           will be met. The supplemental funding                  ACTION:   Notice.
                                                    applications received in response to                    will also ensure that USCRI has
                                                    ‘‘PPHF–2015-Enhanced Surveillance for                   sufficient staff for the increased number              SUMMARY: The Food and Drug
                                                    New Vaccine Preventable Disease—A                       of cases.                                              Administration (FDA) is announcing


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                                                                                    Federal Register / Vol. 80, No. 105 / Tuesday, June 2, 2015 / Notices                                             31385

                                                    that a collection of information entitled               perform outreach to schoolchildren                     the FDA-National Science Teachers
                                                    ‘‘Prescription Drug Marketing Act of                    using FDA-approved food safety and                     Association (NSTA) supplementary food
                                                    1987; Policies, Requirements, and                       nutrition messages. This proposed                      science curriculum SOFS, and includes
                                                    Administrative Procedures’’ has been                    cooperative agreement requires the                     one week of targeted training with this
                                                    approved by the Office of Management                    supporting organization to provide                     curriculum as the basis of instruction. It
                                                    and Budget (OMB) under the Paperwork                    teachers for one school year to extend                 also includes a 1-day Enhancement
                                                    Reduction Act of 1995.                                  CFSAN’s outreach into schools.                         Training session at the December NSTA
                                                    FOR FURTHER INFORMATION CONTACT: FDA                    DATES: The application due date is July                Regional Conference. SOFS content is
                                                    PRA Staff, Office of Operations, Food                   1, 2015, by 11:59 p.m. Eastern Time.                   linked to specific national science
                                                    and Drug Administration, 8455                           ADDRESSES: Submit electronic                           education standards to help teachers
                                                    Colesville Rd., COLE–14526, Silver                      applications to: http://www.grants.gov.                integrate this content into their existing
                                                    Spring, MD 20993–0002, PRAStaff@                        For more information, see section III of               classroom materials. The course covers
                                                    fda.hhs.gov.                                            the SUPPLEMENTARY INFORMATION section                  the latest research on food safety, food
                                                    SUPPLEMENTARY INFORMATION: On March                     of this notice.                                        microbiology, epidemiology, and
                                                    06, 2015, the Agency submitted a                                                                               nutrition from FDA experts and
                                                                                                            FOR FURTHER INFORMATION CONTACT:
                                                    proposed collection of information                                                                             scientists. These 37 teachers must
                                                                                                            Louise Dickerson, Center for Food
                                                    entitled ‘‘Prescription Drug Marketing                                                                         conduct a train-the-teacher session for
                                                                                                            Safety and Applied Nutrition, CPK1,
                                                    Act of 1987; Policies, Requirements, and                                                                       other science teachers in their area of
                                                                                                            Rm. 2C–006 (HFS–008), Food and Drug
                                                    Administrative Procedures’’ to OMB for                                                                         the country on how to successfully use
                                                                                                            Administration, 5100 Paint Branch
                                                    review and clearance under 44 U.S.C.                                                                           SOFS in their classrooms. To date, 620
                                                                                                            Pkwy., College Park, MD 20740, 240–
                                                    3507. An Agency may not conduct or                                                                             teachers have completed the week-long
                                                                                                            402–2129, email:
                                                    sponsor, and a person is not required to                                                                       program, reaching approximately 13,000
                                                                                                            Louise.Dickerson@fda.hhs.gov; or
                                                    respond to, a collection of information                                                                        teachers and more than 7 million
                                                                                                            Kimberly Pendleton Chew, Office of
                                                    unless it displays a currently valid OMB                                                                       students across the country. Teachers in
                                                                                                            Acquisition and Grant Services, FHSL,
                                                    control number. OMB has now                                                                                    this program have represented all 50
                                                                                                            Rm. 2031, Food and Drug
                                                    approved the information collection and                                                                        states, the District of Columbia, the U.S.
                                                                                                            Administration, 5630 Fishers Lane,
                                                    has assigned OMB control number                                                                                Virgin Islands, Guam, and Puerto Rico.
                                                                                                            Rockville, MD 20857, 240–402–7610,
                                                    0910–0435. The approval expires on                      email: Kimberly.Pendleton@fda.hhs.gov.                    In recent years, CFSAN has added
                                                    May 31, 2018. A copy of the supporting                     For more information on this funding                other training and online resources
                                                    statement for this information collection               opportunity announcement (FOA) and                     through the NSTA Learning Center, as
                                                    is available on the Internet at http://                 to obtain detailed requirements, please                well as FDA and Graduate School Web
                                                    www.reginfo.gov/public/do/PRAMain.                      refer to the full FOA located at http://               sites. The grantee shall assume the
                                                                                                            www.grants.gov. Search by Funding                      responsibilities of arranging print and
                                                      Dated: May 28, 2015.                                                                                         electronic program advertisements to
                                                    Leslie Kux,
                                                                                                            Opportunity Number: RFA–FD–15–011.
                                                                                                                                                                   science teachers through science teacher
                                                    Associate Commissioner for Policy.                      SUPPLEMENTARY INFORMATION:
                                                                                                                                                                   journals, Web-based formats, and
                                                    [FR Doc. 2015–13331 Filed 6–1–15; 8:45 am]              I. Funding Opportunity Description                     listservs (where appropriate). The
                                                    BILLING CODE 4164–01–P
                                                                                                            RFA–FD–15–011                                          grantee shall act as a National Training
                                                                                                            93.103                                                 Coordinator for the year-round SOFS
                                                                                                                                                                   content delivery by teachers. In
                                                    DEPARTMENT OF HEALTH AND                                A. Background                                          addition, the grantee shall oversee and
                                                    HUMAN SERVICES                                             This FOA is soliciting an application               coordinate exhibiting at one regional
                                                                                                            from the Graduate School USA to                        NSTA conference in the fall of 2015 and
                                                    Food and Drug Administration                                                                                   one national NSTA conference in spring
                                                                                                            support and extend the education
                                                    [Docket No. FDA–2015–N–0012]                            programs of the Education Team in the                  2016. The goal of this cooperative
                                                                                                            Office of Analytics and Outreach. As                   agreement is to provide continued
                                                    The Food and Drug Administration’s                      part of its mission to promote and                     support for this program, which requires
                                                    Education and Outreach Program                          protect public health, the Education                   around-the-calendar attention to cover
                                                    Targeting School-Aged Children                          Team is tasked to implement targeted                   the various stages of teacher primary
                                                    AGENCY:    Food and Drug Administration,                education programs that reach school-                  training, in-school SOFS curriculum
                                                    HHS.                                                    aged children using FDA-approved food                  implementation, secondary training,
                                                                                                            safety and nutrition messages. This                    and train-the-teacher programs, as well
                                                    ACTION:   Notice; U48.
                                                                                                            cooperative agreement requires the                     as to distribute food science education
                                                    SUMMARY:   The Food and Drug                            grantee to provide 37 teachers for one                 materials to teachers to promote student
                                                    Administration (FDA) is announcing the                  school year to extend CFSAN’s reach                    education in food safety and nutrition.
                                                    availability of grant funds for the                     into additional U.S. schools. The                      B. Research Objectives
                                                    support of the Center for Food Safety                   selected grantee must train and ensure
                                                    and Applied Nutrition’s (CFSAN)                         that these 37 teachers will use the FDA                   Specific objectives of this support are
                                                    Education and Outreach Program                          curriculum Science and Our Food                        to:
                                                    Targeting School-Aged Children (U48).                   Supply (SOFS), which has been                             • Provide 37 teachers from diverse
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    The goal of the Education and Outreach                  approved by FDA scientists. The grantee                U.S. schools a weeklong course in food
                                                    Program Targeting School-Aged                           shall also guarantee that these teachers               science in the Washington, DC
                                                    Children (U48) is to support educational                will use CFSAN’s educational materials                 metropolitan area;
                                                    outreach programs targeting school-aged                 and, in turn, support and promote food                    • distribute approved food science
                                                    children which promotes FDA’s                           safety and nutrition on a national scale.              curricula and other materials for the
                                                    mission. As part of FDA’s mission to                       This cooperative agreement will                     train-the-teacher session and exhibit at
                                                    promote and protect public health, the                  support the commitment of 37 middle                    the national NSTA and regional NSTA
                                                    educational program’s mission is to                     and high school teachers to implement                  conferences; and


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Document Created: 2015-12-15 15:11:45
Document Modified: 2015-12-15 15:11:45
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
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 31384 

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