Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 937 [2016-113]

Download as PDF Federal Register / Vol. 81, No. 5 / Friday, January 8, 2016 / Notices Board of Governors of the Federal Reserve System, January 5, 2016. Michael J. Lewandowski, Associate Secretary of the Board. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–153 Filed 1–7–16; 8:45 am] [Docket No. FDA–2015–D–5073] Food and Drug Administration BILLING CODE 6210–01–P Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and TissueBased Products; Draft Guidance for Industry; Availability DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention AGENCY: asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 the aforementioned meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) PAR15–352, Occupational Safety and Health Training Project Grants. Time and Date: 8:00 a.m.–7:00 p.m., January 26–28, 2016 (Closed). Place: Internet Assisted Meeting (IAM)/Virtual Meeting. 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 Occupational Safety and Health Training Project Grants, FOA PAR15– 352, initial review. Contact Person For More Information: Donald Blackman, Ph.D., Scientific Review Officer, CDC, 2400 Century Center Parkway NE., 4th Floor, Room 4204, Mailstop E–74, Atlanta, Georgia 30345, Telephone: (404) 498–6185, DYB7@CDC.GOV. 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 Prevention and the Agency for Toxic Substances and Disease Registry. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2016–113 Filed 1–7–16; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 20:40 Jan 07, 2016 Jkt 238001 Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry.’’ The draft guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The draft guidance, when finalized, is intended to supplement previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ‘‘Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)’’ dated August 2007 (2007 Donor Eligibility Guidance). SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 7, 2016. ADDRESSES: You may submit comments as follows: DATES: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 937 the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–D–5073 for ‘‘Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue Based Products; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the E:\FR\FM\08JAN1.SGM 08JAN1

Agencies

[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Page 937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-113]


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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 the aforementioned meeting for the initial 
review of applications in response to Funding Opportunity Announcement 
(FOA) PAR15-352, Occupational Safety and Health Training Project 
Grants.
    Time and Date: 8:00 a.m.-7:00 p.m., January 26-28, 2016 (Closed).
    Place: Internet Assisted Meeting (IAM)/Virtual Meeting.
    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 Occupational Safety and Health Training Project Grants, FOA PAR15-
352, initial review.
    Contact Person For More Information: Donald Blackman, Ph.D., 
Scientific Review Officer, CDC, 2400 Century Center Parkway NE., 4th 
Floor, Room 4204, Mailstop E-74, Atlanta, Georgia 30345, Telephone: 
(404) 498-6185, DYB7@CDC.GOV.
    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 Prevention and the Agency 
for Toxic Substances and Disease Registry.

Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2016-113 Filed 1-7-16; 8:45 am]
 BILLING CODE 4163-18-P