80 FR 15616 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 56 (March 24, 2015)

Page Range		15616-15617
FR Document		2015-06601

Federal Register, Volume 80 Issue 56 (Tuesday, March 24, 2015)

[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15616-15617]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06601]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Notice of Closed 
Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    The meetings 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 Heart, Lung, and Blood Institute 
Special Emphasis Panel; Basic Research in HIV-Related Heart, Lung 
and Blood Diseases.
    Time: April 16, 2015.
    Time: 8:00 a.m. to 11:00 a.m.
    Agenda: To review and evaluate grant applications.
    Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New 
Hampshire Avenue NW., Washington, DC 20037.
    Contact Person: Susan Wohler Sunnarborg, Ph.D. Scientific Review 
Officer, Office of Scientific Review/DERA National, Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 
20892, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Translational Programs in Lung Diseases.
    Date: April 16, 2015.
    Time: 8:30 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Crystal City Marriott, 1999 Jefferson Davis Highway, 
Arlington, VA 22202.
    Contact Person: William J. Johnson, Ph.D., Scientific Review 
Officer, Office of Scientific Review/DERA, National Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 
20892-7924, 301-435-0725, [email protected].

    Name of Committee: National Heart, Lung, and Blood Institute 
Special Emphasis Panel; Basic Research in HIV-Related Heart, Lung 
and Blood Diseases (R21).
    Date: April 16, 2015.
    Time: 11:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Renaissance Washington, DC Dupont Circle Hotel, 1143 New 
Hampshire Avenue NW., Washington, DC 20037.
    Contact Person: Susan Wohler Sunnarborg, Ph.D. Scientific Review 
Officer, Office of Scientific Review/DERA National, Heart, Lung, and 
Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 
20892, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.233, 
National Center for Sleep Disorders Research; 93.837, Heart and 
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, 
Blood Diseases and Resources Research, National Institutes of 
Health, HHS)



[[Page 15617]]


    Dated: March 18, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-06601 Filed 3-23-15; 8:45 am]
BILLING CODE 4140-01-P

15616 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices

Group 3 will receive a mailing about the Providers who do or would diagnose/ attend by the neurologist) with
registry, whereas Group 4 the care for patients with ALS will receive information to educate persons with
comparison group will not receive any a targeted mailing about the registry. ALS about the National ALS Registry
outreach component. To analyze the Follow-up phone calls and faxes, as self-enrollment process. The train-the-
change in ALS registry self-enrollment, needed, will confirm the receipt of trainer module activities do not involve
ATSDR will compare, on a monthly mailings (including posters, provider information collections.
basis, enrollment rates between Groups guide pamphlet, Persons with ALS
Participation is voluntary. For the
1, 2, and 3, and 4, as well as with the Quick Start Guide etc.). Key informant
duration (2 years), the project staff will
44-state Group 4. interviews with neurologists will allow
Study activities include, but are not conduct 3,800 initial phone calls, 1,900
for better understanding of their
limited to, initial and follow-up phone follow-up #1 calls at one week post-
knowledge, attitudes, and beliefs about
calls, mailings, train-the-trainer the Registry, and for gathering mailing, 1,900 follow-up #2 calls at
sessions, and key informant interviews. additional information about the three months post-mailing, 30 train-the-
The initial phone call will: (1) currently deployed Registry materials. trainer presentations, and 32 key-
determine if the neurologist(s) diagnose/ As neurologists may not be familiar informant interviews.
care for patients with ALS; (2) with the self-enrollment process of the There are no costs to respondents
determine how many ALS patients are Registry, the project includes train-the- other than their time. The estimated
seen on an annual basis, and (3) confirm trainer site visits that will provide annualized burden hours for this data
contact information for neurologists. neurologists and staff (if requested to collection activity are 326.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)

Neurologist Support Staff .................. Initial Phone Call Checklist .............. 1,900 1 6/60 190
Neurologist Support Staff .................. Fax to Determine Provider Status ... 380 1 1/60 6
Neurologist Support Staff .................. Follow-up Phone Call #1 (One 950 1 3/60 48
Week Post-Mailing).
Neurologist Support Staff .................. Follow-up Phone Call #2 (Three 950 1 3/60 48
Months Post-Mailing).
Neurologist Support Staff .................. Fax to Determine if Mailing Was Re- 190 1 1/60 3
ceived.
Neurologist ........................................ Train-the-Trainer .............................. 15 1 1 15
Neurologist ........................................ Key Informant Interview ................... 16 1 1 16

Total ........................................... ........................................................... ........................ ........................ ........................ 326

Leroy A. Richardson, individuals associated with the grant Review/DERA, National Heart, Lung, and
Chief, Information Collection Review Office, applications, the disclosure of which Blood Institute, 6701 Rockledge Drive, Room
Office of Scientific Integrity, Office of the would constitute a clearly unwarranted 7178, Bethesda, MD 20892–7924, 301–435–
Associate Director for Science, Office of the invasion of personal privacy. 0725, johnsonwj@nhlbi.nih.gov.
Director, Centers for Disease Control and Name of Committee: National Heart, Lung,
Prevention. Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel; and Blood Institute Special Emphasis Panel;
[FR Doc. 2015–06654 Filed 3–23–15; 8:45 am] Basic Research in HIV-Related Heart, Lung
Basic Research in HIV-Related Heart, Lung
BILLING CODE 4163–18–P and Blood Diseases. and Blood Diseases (R21).
Time: April 16, 2015. Date: April 16, 2015.
Time: 8:00 a.m. to 11:00 a.m. Time: 11:00 a.m. to 5:00 p.m.
DEPARTMENT OF HEALTH AND Agenda: To review and evaluate grant Agenda: To review and evaluate grant
HUMAN SERVICES applications.
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire Place: Renaissance Washington, DC
National Institutes of Health
Avenue NW., Washington, DC 20037. Dupont Circle Hotel, 1143 New Hampshire
National Heart, Lung, and Blood Contact Person: Susan Wohler Sunnarborg, Avenue NW., Washington, DC 20037.
Institute; Notice of Closed Meetings Ph.D. Scientific Review Officer, Office of Contact Person: Susan Wohler Sunnarborg,
Scientific Review/DERA National, Heart, Ph.D. Scientific Review Officer, Office of
Pursuant to section 10(d) of the Lung, and Blood Institute, 6701 Rockledge Scientific Review/DERA National, Heart,
Federal Advisory Committee Act, as Drive, Room 7182, Bethesda, MD 20892, Lung, and Blood Institute, 6701 Rockledge
amended (5 U.S.C. App.), notice is sunnarborgsw@nhlbi.nih.gov. Drive, Room 7182, Bethesda, MD 20892,
hereby given of the following meetings. Name of Committee: National Heart, Lung, sunnarborgsw@nhlbi.nih.gov.
The meetings will be closed to the and Blood Institute Special Emphasis Panel;
(Catalogue of Federal Domestic Assistance
mstockstill on DSK4VPTVN1PROD with NOTICES

public in accordance with the Translational Programs in Lung Diseases.
Date: April 16, 2015. Program Nos. 93.233, National Center for
provisions set forth in sections Sleep Disorders Research; 93.837, Heart and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant Vascular Diseases Research; 93.838, Lung
as amended. The grant applications and applications. Diseases Research; 93.839, Blood Diseases
the discussions could disclose Place: Crystal City Marriott, 1999 Jefferson and Resources Research, National Institutes
confidential trade secrets or commercial Davis Highway, Arlington, VA 22202. of Health, HHS)
property such as patentable material, Contact Person: William J. Johnson, Ph.D.,
and personal information concerning Scientific Review Officer, Office of Scientific

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Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 15617

Dated: March 18, 2015. for electronic access to the guidance public. An alternative approach may be
Michelle Trout, document. used if such approach satisfies the
Program Analyst, Office of Federal Advisory Submit electronic comments on the requirements of the applicable statutes
Committee Policy. guidance to http://www.regulations.gov. and regulations.
[FR Doc. 2015–06601 Filed 3–23–15; 8:45 am] Submit written comments to the
II. Paperwork Reduction Act of 1995
BILLING CODE 4140–01–P Division of Dockets Management (HFA–
305), Food and Drug Administration, This guidance refers to previously
5630 Fishers Lane, Rm. 1061, Rockville, approved collections of information
DEPARTMENT OF HEALTH AND MD 20852. found in FDA regulations. These
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: collections of information are subject to
Tami Belouin, Center for Biologics review by the Office of Management and
Food and Drug Administration Evaluation and Research, Food and Budget (OMB) under the Paperwork
Drug Administration, 10903 New Reduction Act of 1995 (44 U.S.C. 3501–
[Docket No. FDA–2014–D–0663] 3520). The collections of information in
Hampshire Ave., Bldg. 71, Rm. 7301,
Determining the Need for and Content Silver Spring, MD 20993–0002, 240– 21 CFR part 25 have been approved
of Environmental Assessments for 402–7911. under OMB control number 0910–0322;
Gene Therapies, Vectored Vaccines, the collections of information in 21 CFR
SUPPLEMENTARY INFORMATION:
and Related Recombinant Viral or part 312 have been approved under
Microbial Products; Guidance for I. Background OMB control number 0910–0014; and
Industry: Availability FDA is announcing the availability of the collections of information for 21
a document entitled ‘‘Determining the CFR part 601 have been approved under
AGENCY: Food and Drug Administration, Need for and Content of Environmental OMB control number 0910–0338.
HHS. Assessments for Gene Therapies, III. Comments
ACTION: Notice. Vectored Vaccines, and Related
Interested persons may submit either
Recombinant Viral or Microbial
SUMMARY: The Food and Drug electronic comments regarding this
Products; Guidance for Industry’’ dated
Administration (FDA) is announcing the document to http://www.regulations.gov
March 2015. The guidance document
availability of a document entitled or written comments to the Division of
provides IND sponsors and applicants
‘‘Determining the Need for and Content Dockets Management (see ADDRESSES). It
for a BLA or a BLA supplement, with
of Environmental Assessments for Gene is only necessary to send one set of
recommendations on considerations
Therapies, Vectored Vaccines, and comments. Identify comments with the
when assessing whether to submit an
Related Recombinant Viral or Microbial docket number found in brackets in the
EA for GTVVs. The guidance also
Products; Guidance for Industry’’ dated heading of this document. Received
contains recommendations as to what
March 2015. The guidance document comments may be seen in the Division
information should be included in an
provides investigational new drug of Dockets Management between 9 a.m.
EA and what you can expect once an EA
application (IND) sponsors and and 4 p.m., Monday through Friday, and
is filed. The guidance supplements the
applicants for a biologics license will be posted to the docket at http://
guidance entitled ‘‘Guidance for
application (BLA) or a supplement to a www.regulations.gov.
Industry: Environmental Assessment of
BLA (BLA supplement), with Human Drug and Biologics IV. Electronic Access
recommendations on considerations Applications’’ dated July 1998 (July 27,
when assessing whether to submit an Persons with access to the Internet
1998, 63 FR 40127) (1998 Guidance) and may obtain the guidance at either http://
Environmental Assessment (EA) for supersedes the recommendations for
gene therapies, vectored vaccines, and www.fda.gov/BiologicsBloodVaccines/
GTVVs in section IV.B.1 ‘‘Assessing GuidanceComplianceRegulatory
related recombinant viral or microbial Toxicity to Environmental Organisms’’
products (GTVVs). The guidance also Information/Guidances/default.htm or
in the 1998 Guidance. The guidance http://www.regulations.gov.
contains recommendations as to what announced in this notice finalizes the
information should be included in an draft guidance of the same title dated Dated: March 19, 2015.
EA and what you can expect once an EA June 2014. Leslie Kux,
is filed. The guidance announced in this In the Federal Register of June 20, Associate Commissioner for Policy.
notice finalizes the draft guidance of the 2014 (79 FR 35361), FDA announced the [FR Doc. 2015–06686 Filed 3–23–15; 8:45 am]
same title dated June 2014. availability of the draft guidance of the BILLING CODE 4164–01–P
DATES: Submit either electronic or same title dated June 2014. FDA
written comments on Agency guidances received a few comments on the draft
at any time. guidance and those comments were DEPARTMENT OF HEALTH AND
ADDRESSES: Submit written requests for considered as the guidance was HUMAN SERVICES
single copies of the guidance to the finalized. There were no changes to the
Office of Communication, Outreach and guidance except for one correction to a Centers for Disease Control and
Development, Center for Biologics technical error regarding influenza Prevention
Evaluation and Research (CBER), Food taxonomy. The guidance announced in Disease, Disability, and Injury
and Drug Administration, 10903 New this notice finalizes the draft guidance Prevention and Control Special
mstockstill on DSK4VPTVN1PROD with NOTICES

Hampshire Ave., Bldg. 71, Rm. 3128, dated June 2014. Emphasis Panel (SEP): Initial Review
Silver Spring, MD 20993–0002. Send The guidance is being issued
one self-addressed adhesive label to consistent with FDA’s good guidance The meeting announced below
assist the office in processing your practices regulation (21 CFR 10.115). concerns Economic Studies of
requests. The guidance may also be The guidance represents FDA’s current Immunization Policies and Practices,
obtained by mail by calling CBER at 1– thinking on this topic. It does not create Funding Opportunity Announcement
800–835–4709 or 240–402–7800. See or confer any rights for or on any person (FOA) IP15–001 and US Platform to
the SUPPLEMENTARY INFORMATION section and does not operate to bind FDA or the Measure Influenza Vaccine

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Document Created: 2015-12-18 11:44:41
Document Modified: 2015-12-18 11:44:41

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		April 16, 2015.
FR Citation		80 FR 15616

80 FR 15616 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 56 (March 24, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health