National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 15616-15617 [2015-06601]

Download as PDF 15616 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices Group 3 will receive a mailing about the registry, whereas Group 4 the comparison group will not receive any outreach component. To analyze the change in ALS registry self-enrollment, ATSDR will compare, on a monthly basis, enrollment rates between Groups 1, 2, and 3, and 4, as well as with the 44-state Group 4. Study activities include, but are not limited to, initial and follow-up phone calls, mailings, train-the-trainer sessions, and key informant interviews. The initial phone call will: (1) determine if the neurologist(s) diagnose/ care for patients with ALS; (2) determine how many ALS patients are seen on an annual basis, and (3) confirm contact information for neurologists. Providers who do or would diagnose/ care for patients with ALS will receive a targeted mailing about the registry. Follow-up phone calls and faxes, as needed, will confirm the receipt of mailings (including posters, provider guide pamphlet, Persons with ALS Quick Start Guide etc.). Key informant interviews with neurologists will allow for better understanding of their knowledge, attitudes, and beliefs about the Registry, and for gathering additional information about the currently deployed Registry materials. As neurologists may not be familiar with the self-enrollment process of the Registry, the project includes train-thetrainer site visits that will provide neurologists and staff (if requested to attend by the neurologist) with information to educate persons with ALS about the National ALS Registry self-enrollment process. The train-thetrainer module activities do not involve information collections. Participation is voluntary. For the duration (2 years), the project staff will conduct 3,800 initial phone calls, 1,900 follow-up #1 calls at one week postmailing, 1,900 follow-up #2 calls at three months post-mailing, 30 train-thetrainer presentations, and 32 keyinformant interviews. There are no costs to respondents other than their time. The estimated annualized burden hours for this data collection activity are 326. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average burden per response (in hours) Number of responses per respondent Total burden (in hours) Type of respondent Form name Neurologist Support Staff .................. Neurologist Support Staff .................. Neurologist Support Staff .................. 1,900 380 950 1 1 1 6/60 1/60 3/60 190 6 48 950 1 3/60 48 190 1 1/60 3 Neurologist ........................................ Neurologist ........................................ Initial Phone Call Checklist .............. Fax to Determine Provider Status ... Follow-up Phone Call #1 (One Week Post-Mailing). Follow-up Phone Call #2 (Three Months Post-Mailing). Fax to Determine if Mailing Was Received. Train-the-Trainer .............................. Key Informant Interview ................... 15 16 1 1 1 1 15 16 Total ........................................... ........................................................... ........................ ........................ ........................ 326 Neurologist Support Staff .................. Neurologist Support Staff .................. Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015–06654 Filed 3–23–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK4VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 01:09 Mar 24, 2015 Jkt 235001 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, sunnarborgsw@nhlbi.nih.gov. 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 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD 20892–7924, 301–435– 0725, johnsonwj@nhlbi.nih.gov. 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, sunnarborgsw@nhlbi.nih.gov. (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) E:\FR\FM\24MRN1.SGM 24MRN1 Federal Register / Vol. 80, No. 56 / Tuesday, March 24, 2015 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0663] Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry: Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry’’ dated March 2015. The guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA) or a supplement to a BLA (BLA supplement), with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–7800. See the SUPPLEMENTARY INFORMATION section mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 01:09 Mar 24, 2015 Jkt 235001 for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry’’ dated March 2015. The guidance document provides IND sponsors and applicants for a BLA or a BLA supplement, with recommendations on considerations when assessing whether to submit an EA for GTVVs. The guidance also contains recommendations as to what information should be included in an EA and what you can expect once an EA is filed. The guidance supplements the guidance entitled ‘‘Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications’’ dated July 1998 (July 27, 1998, 63 FR 40127) (1998 Guidance) and supersedes the recommendations for GTVVs in section IV.B.1 ‘‘Assessing Toxicity to Environmental Organisms’’ in the 1998 Guidance. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2014. In the Federal Register of June 20, 2014 (79 FR 35361), FDA announced the availability of the draft guidance of the same title dated June 2014. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. There were no changes to the guidance except for one correction to a technical error regarding influenza taxonomy. The guidance announced in this notice finalizes the draft guidance dated June 2014. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 15617 public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 25 have been approved under OMB control number 0910–0322; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; and the collections of information for 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: March 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–06686 Filed 3–23–15; 8:45 am] BILLING CODE 4164–01–P 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 The meeting announced below concerns Economic Studies of Immunization Policies and Practices, Funding Opportunity Announcement (FOA) IP15–001 and US Platform to Measure Influenza Vaccine E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15616-15617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06601]


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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, sunnarborgsw@nhlbi.nih.gov.

    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, johnsonwj@nhlbi.nih.gov.

    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, sunnarborgsw@nhlbi.nih.gov.

(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
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