Advisory Committee; Science Board to the Food and Drug Administration, Renewal, 47396-47397 [2016-17182]

Download as PDF 47396 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 2016)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 306 of the Public Health Service (PHS) Act (42 U.S.C.), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the extent and nature of illness and disability of the population of the United States. The National Death Index (NDI) is a national data base containing identifying death record information submitted annually to NCHS by all the state vital statistics offices, beginning with deaths in 1979. Searches against update the three data collection forms submitted by NDI users when applying for use of the NDI and when actually using the service. The form updates include editorial changes needed to capture current modes of data transfer and service payment options, direction clarifications, the inclusion of an item to capture any resulting publications, as well as, additional terms and condition associated with the confidentiality agreement. There is no cost to respondents except for their time. The total estimated annual burden hours are 507, an increase of 325 hours due to an anticipated increase of both the number of applicants and an overall average increased time to complete the application form. the NDI file provide the states and dates of death, and the death certificate numbers of deceased study subjects. Using the NDI Plus service, researchers have the option of also receiving cause of death information for deceased subjects, thus reducing the need to request copies of death certificates from the states. The NDI Plus option currently provides the International Classification of Disease (ICD) codes for the underlying and multiple causes of death for the years 1979–2015. Health researchers must complete administrative forms in order to apply for NDI services, and submit records of study subjects for computer matching against the NDI file. A threeyear Revision request is submitted to ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden hours Type of respondent Form name Researchers ...................................... Researchers ...................................... Researchers ...................................... Application Form .............................. Repeat Request Form ...................... Data Transmittal Form ..................... 100 70 120 1 1 1 4.5 18/60 18/60 450 21 36 Total ........................................... ........................................................... ........................ ........................ ........................ 507 Jeffrey M. Zirger, Acting 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. 2016–17170 Filed 7–20–16; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Advisory Committee; Science Board to the Food and Drug Administration, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 expiration date. The new charter will be in effect until June 26, 2018. DATES: Authority for the Science Board to the Food and Drug Administration will expire on June 26, 2018, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–4769, rakesh.raghuwanshi@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Science Board to the Food and Drug Administration. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Science Board advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Science Board shall provide advice to the Commissioner and other appropriate officials on specific complex scientific PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board will provide advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda; and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. The Committee shall consist of a core of 21 voting members including a Chair and Co-Chair. The members, Chair and Co-Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of food science, safety, and nutrition; chemistry; pharmacology; translational and clinical medicine and research; toxicology; biostatistics; medical devices; imaging; robotics; cell and tissue based products; regenerative medicine; public health and epidemiology; international health and regulation; product safety; product manufacturing sciences and quality; and other scientific areas relevant to FDA regulated products such as systems biology, informatics, nanotechnology, and combination products. Members E:\FR\FM\21JYN1.SGM 21JYN1 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices will be invited to serve for overlapping terms of up to 4 years. Almost all nonFederal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumeroriented organizations or other interested persons. The Committee may also include technically qualified federal members. Further information regarding the most recent charter and other information can be found at http:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/ ScienceBoardtotheFoodand DrugAdministration/ucm115356.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: July 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17182 Filed 7–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0155 (formerly 2005D–0219)] General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry #3 entitled ‘‘General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in FoodProducing Animals.’’ This draft revised guidance describes the type of information that FDA’s Center for Veterinary Medicine (CVM) asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 recommends sponsors provide to address the human food safety of new animal drugs used in food-producing animals. 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 September 19, 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 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– 2005–D–0155 for ‘‘General Principles for Evaluating the Human Food Safety PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 47397 of New Animal Drugs used in FoodProducing Animals.’’ 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 claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. E:\FR\FM\21JYN1.SGM 21JYN1

Agencies

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47396-47397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Science Board to the Food and Drug 
Administration, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Science Board to the Food and Drug Administration by the 
Commissioner of Food and Drugs (the Commissioner). The Commissioner has 
determined that it is in the public interest to renew the Science Board 
to the Food and Drug Administration for an additional 2 years beyond 
the charter expiration date. The new charter will be in effect until 
June 26, 2018.

DATES: Authority for the Science Board to the Food and Drug 
Administration will expire on June 26, 2018, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-4769, rakesh.raghuwanshi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Science Board to the Food and Drug Administration. The 
committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Science Board advises the 
Commissioner or designee in discharging responsibilities as they relate 
to helping to ensure safe and effective drugs for human use and, as 
required, any other product for which FDA has regulatory 
responsibility. The Science Board shall provide advice to the 
Commissioner and other appropriate officials on specific complex 
scientific and technical issues important to FDA and its mission, 
including emerging issues within the scientific community. 
Additionally, the Science Board will provide advice that supports the 
Agency in keeping pace with technical and scientific developments, 
including in regulatory science; and input into the Agency's research 
agenda; and on upgrading its scientific and research facilities and 
training opportunities. It will also provide, where requested, expert 
review of Agency-sponsored intramural and extramural scientific 
research programs.
    The Committee shall consist of a core of 21 voting members 
including a Chair and Co-Chair. The members, Chair and Co-Chair are 
selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of food science, safety, and nutrition; 
chemistry; pharmacology; translational and clinical medicine and 
research; toxicology; biostatistics; medical devices; imaging; 
robotics; cell and tissue based products; regenerative medicine; public 
health and epidemiology; international health and regulation; product 
safety; product manufacturing sciences and quality; and other 
scientific areas relevant to FDA regulated products such as systems 
biology, informatics, nanotechnology, and combination products. Members

[[Page 47397]]

will be invited to serve for overlapping terms of up to 4 years. Almost 
all non-Federal members of this committee serve as Special Government 
Employees. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. The Committee may also include technically qualified federal 
members.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm115356.htm or by contacting the Designated Federal Officer (see FOR 
FURTHER INFORMATION CONTACT). In light of the fact that no change has 
been made to the committee name or description of duties, no amendment 
will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17182 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P