82_FR_58860 82 FR 58622 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

82 FR 58622 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 238 (December 13, 2017)

Page Range58622-58622
FR Document2017-26799

Federal Register, Volume 82 Issue 238 (Wednesday, December 13, 2017)
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Page 58622]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases; Notice of 
Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious 
Diseases Special Emphasis Panel; NIAID Investigator Initiated 
Program Project Applications (P01).
    Date: January 17, 2018.
    Time: 11:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5601 Fishers Lane, 
Rockville, MD 20892, (Telephone Conference Call).
    Contact Person: Eleazar Cohen, Ph.D., Scientific Review Officer, 
Scientific Review Program, Division of Extramural Activities, Room 
3G62A, National Institute of Health, NIAID, 5601 Fishers Lane, MSC 
9823, Bethesda, MD 20899-823, (240) 669-5081, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.855, 
Allergy, Immunology, and Transplantation Research; 93.856, 
Microbiology and Infectious Diseases Research, National Institutes 
of Health, HHS)

    Dated: December 6, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-26799 Filed 12-12-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                58622                         Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices

                                                collection of information to OMB for                               communicating with their intended                         day notice requesting public comment
                                                review and clearance.                                              audiences.                                                on the proposed extension of the
                                                                                                                      FDA will use these methods to test                     collection of information. One comment
                                                Data To Support Drug Product                                       and refine its ideas and to help develop
                                                Communications as Used by the Food                                                                                           was received requesting that FDA
                                                                                                                   messages and other communications but                     publish an annual list of its planned
                                                and Drug Administration                                            will generally conduct further research                   drug product communication studies
                                                OMB Control Number 0910–0695—                                      before making important decisions, such                   and strive to reflect an overall work
                                                Extension                                                          as adopting new policies and allocating                   plan. The comment also noted the rather
                                                                                                                   or redirecting significant resources to
                                                   This information collection supports                                                                                      broad topic areas included in the
                                                                                                                   support these policies. FDA will use
                                                Agency outreach efforts. Testing of                                                                                          information collection and suggested
                                                                                                                   this mechanism to test messages about
                                                communication messages in advance of                               regulated drug products on a variety of                   that perhaps additional notice regarding
                                                a communication campaign provides an                               subjects related to consumer, patient, or                 individual studies would allow for more
                                                important role in improving FDA                                    health care professional perceptions and                  meaningful feedback on whether that
                                                communications as they allow for an in-                            about use of drug products and related                    particular study would be necessary.
                                                depth understanding of individuals’                                materials, including but not limited to,                  FDA appreciates this comment. In
                                                attitudes, beliefs, motivations, and                               direct-to-consumer prescription drug                      determining which drug product
                                                feelings. The methods to be employed                               promotion, physician labeling of                          communications it will undertake, we
                                                include individual in-depth interviews,                            prescription drugs, medication guides,                    first consider those we believe will best
                                                general public focus group interviews,                             over-the-counter drug labeling,                           address current or immediate public
                                                intercept interviews, self-administered                            emerging risk communications, patient                     health issues. We also note that, in
                                                surveys, gatekeeper surveys, and                                   labeling, online sale of medical                          accordance with the PRA, any proposed
                                                professional clinician focus group                                 products, and consumer and                                study under this information collection
                                                interviews, all on a voluntary basis. The                          professional education. Annually, FDA                     request must first be submitted to and
                                                methods to be used serve the narrowly                              projects about 45 communication                           approved by OMB to determine whether
                                                defined need for direct and informal                               studies using the variety of test methods                 it falls within the scope of the
                                                opinion on a specific topic and, as a                              listed in this document. FDA is                           collection. At the same time, as
                                                qualitative research tool, have two major                          requesting an extension of these burden                   resources are available, we will make
                                                purposes: To obtain information that is                            hours so as not to restrict the Agency’s                  every effort to communicate to our
                                                useful for developing variables and                                ability to gather information on public
                                                measures for formulating the basic                                                                                           stakeholders anticipated studies so that
                                                                                                                   sentiment for its proposals in its
                                                objectives of risk communication                                                                                             ongoing or related research can be
                                                                                                                   regulatory and communications
                                                campaigns, and to assess the potential                             programs.                                                 coordinated.
                                                effectiveness of messages and materials                               In the Federal Register of June 19,                       We therefore estimate the burden of
                                                in reaching and successfully                                       2017 (82 FR 27840), we published a 60-                    this collection of information as follows:
                                                                                                        TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                                                             Average
                                                                                                                                                     Number of
                                                                                                                              Number of                               Total annual         burden per
                                                                               Activity                                                            responses per                                                Total hours
                                                                                                                             respondents                               responses            response
                                                                                                                                                     respondent                             (in hours)

                                                Interviews/Surveys .....................................................               19,822                    1          19,822    0.24 (14 minutes) ....           4,757
                                                   1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                  Dated: December 5, 2017.                                         552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                Program, Division of Extramural Activities,
                                                Leslie Kux,                                                        as amended. The grant applications and                    Room 3G62A, National Institute of Health,
                                                Associate Commissioner for Policy.                                 the discussions could disclose                            NIAID, 5601 Fishers Lane, MSC 9823,
                                                [FR Doc. 2017–26795 Filed 12–12–17; 8:45 am]                       confidential trade secrets or commercial                  Bethesda, MD 20899–823, (240) 669–5081,
                                                                                                                   property such as patentable material,                     ecohen@niaid.nih.gov.
                                                BILLING CODE 4164–01–P
                                                                                                                   and personal information concerning                       (Catalogue of Federal Domestic Assistance
                                                                                                                   individuals associated with the grant                     Program Nos. 93.855, Allergy, Immunology,
                                                DEPARTMENT OF HEALTH AND                                           applications, the disclosure of which                     and Transplantation Research; 93.856,
                                                HUMAN SERVICES                                                     would constitute a clearly unwarranted                    Microbiology and Infectious Diseases
                                                                                                                   invasion of personal privacy.                             Research, National Institutes of Health, HHS)
                                                National Institutes of Health                                        Name of Committee: National Institute of                  Dated: December 6, 2017.
                                                                                                                   Allergy and Infectious Diseases Special
                                                National Institute of Allergy and                                                                                            Natasha M. Copeland,
                                                                                                                   Emphasis Panel; NIAID Investigator Initiated
                                                Infectious Diseases; Notice of Closed                              Program Project Applications (P01).                       Program Analyst, Office of Federal Advisory
                                                Meeting                                                              Date: January 17, 2018.                                 Committee Policy.
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                                                                                                                     Time: 11:00 a.m. to 4:00 p.m.                           [FR Doc. 2017–26799 Filed 12–12–17; 8:45 am]
                                                  Pursuant to section 10(d) of the
                                                                                                                     Agenda: To review and evaluate grant                    BILLING CODE 4140–01–P
                                                Federal Advisory Committee Act, as
                                                                                                                   applications.
                                                amended, notice is hereby given of the                               Place: National Institutes of Health, 5601
                                                following meeting.                                                 Fishers Lane, Rockville, MD 20892,
                                                  The meeting will be closed to the                                (Telephone Conference Call).
                                                public in accordance with the                                        Contact Person: Eleazar Cohen, Ph.D.,
                                                provisions set forth in sections                                   Scientific Review Officer, Scientific Review



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Document Created: 2017-12-13 01:23:59
Document Modified: 2017-12-13 01:23:59
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
DatesJanuary 17, 2018.
FR Citation82 FR 58622 

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