81_FR_47536 81 FR 47396 - Advisory Committee; Science Board to the Food and Drug Administration, Renewal

81 FR 47396 - Advisory Committee; Science Board to the Food and Drug Administration, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 140 (July 21, 2016)

Page Range47396-47397
FR Document2016-17182

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.

Federal Register, Volume 81 Issue 140 (Thursday, July 21, 2016) 
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Notices]
[Pages 47396-47397]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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, [email protected].

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

47396 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 2016)—Revision—National Center for the NDI file provide the states and dates update the three data collection forms Health Statistics (NCHS), Centers for of death, and the death certificate submitted by NDI users when applying Disease Control and Prevention (CDC). numbers of deceased study subjects. for use of the NDI and when actually Using the NDI Plus service, using the service. The form updates Background and Brief Description researchers have the option of also include editorial changes needed to Section 306 of the Public Health receiving cause of death information for capture current modes of data transfer Service (PHS) Act (42 U.S.C.), as deceased subjects, thus reducing the and service payment options, direction amended, authorizes that the Secretary need to request copies of death clarifications, the inclusion of an item to of Health and Human Services (DHHS), certificates from the states. The NDI capture any resulting publications, as acting through NCHS, shall collect Plus option currently provides the well as, additional terms and condition statistics on the extent and nature of International Classification of Disease associated with the confidentiality illness and disability of the population (ICD) codes for the underlying and agreement. There is no cost to of the United States. multiple causes of death for the years respondents except for their time. The The National Death Index (NDI) is a 1979–2015. Health researchers must total estimated annual burden hours are national data base containing complete administrative forms in order 507, an increase of 325 hours due to an identifying death record information to apply for NDI services, and submit anticipated increase of both the number submitted annually to NCHS by all the records of study subjects for computer of applicants and an overall average state vital statistics offices, beginning matching against the NDI file. A three- increased time to complete the with deaths in 1979. Searches against year Revision request is submitted to application form. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondent Form name responses per respondents response hours respondent (in hours) Researchers ...................................... Application Form .............................. 100 1 4.5 450 Researchers ...................................... Repeat Request Form ...................... 70 1 18/60 21 Researchers ...................................... Data Transmittal Form ..................... 120 1 18/60 36 Total ........................................... ........................................................... ........................ ........................ ........................ 507 Jeffrey M. Zirger, expiration date. The new charter will be and technical issues important to FDA Acting Chief, Information Collection Review in effect until June 26, 2018. and its mission, including emerging Office, Office of Scientific Integrity, Office DATES: Authority for the Science Board issues within the scientific community. of the Associate Director for Science, Office to the Food and Drug Administration Additionally, the Science Board will of the Director, Centers for Disease Control provide advice that supports the Agency and Prevention. will expire on June 26, 2018, unless the Commissioner formally determines that in keeping pace with technical and [FR Doc. 2016–17170 Filed 7–20–16; 8:45 am] renewal is in the public interest. scientific developments, including in BILLING CODE 4163–18–P regulatory science; and input into the FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Agency’s research agenda; and on Chief Scientist, Office of the upgrading its scientific and research DEPARTMENT OF HEALTH AND Commissioner, Food and Drug facilities and training opportunities. It HUMAN SERVICES Administration, Bldg. 1, Rm. 3309, will also provide, where requested, Food and Drug Administration 10903 New Hampshire Ave., Silver expert review of Agency-sponsored Spring, MD 20993, 301–796–4769, intramural and extramural scientific rakesh.raghuwanshi@fda.hhs.gov. research programs. [Docket No. FDA–2016–N–0001] SUPPLEMENTARY INFORMATION: Pursuant The Committee shall consist of a core Advisory Committee; Science Board to to 41 CFR 102–3.65 and approval by the of 21 voting members including a Chair the Food and Drug Administration, Department of Health and Human and Co-Chair. The members, Chair and Renewal Services pursuant to 45 CFR part 11 and Co-Chair are selected by the by the General Services Administration, Commissioner or designee from among AGENCY: Food and Drug Administration, FDA is announcing the renewal of the authorities knowledgeable in the fields HHS. Science Board to the Food and Drug of food science, safety, and nutrition; ACTION:Notice; renewal of advisory Administration. The committee is a chemistry; pharmacology; translational committee. discretionary Federal advisory and clinical medicine and research; committee established to provide advice toxicology; biostatistics; medical SUMMARY: The Food and Drug to the Commissioner. The Science Board devices; imaging; robotics; cell and Administration (FDA) is announcing the advises the Commissioner or designee tissue based products; regenerative asabaliauskas on DSK3SPTVN1PROD with NOTICES renewal of the Science Board to the in discharging responsibilities as they medicine; public health and Food and Drug Administration by the relate to helping to ensure safe and epidemiology; international health and Commissioner of Food and Drugs (the effective drugs for human use and, as regulation; product safety; product Commissioner). The Commissioner has required, any other product for which manufacturing sciences and quality; and determined that it is in the public FDA has regulatory responsibility. The other scientific areas relevant to FDA interest to renew the Science Board to Science Board shall provide advice to regulated products such as systems the Food and Drug Administration for the Commissioner and other appropriate biology, informatics, nanotechnology, an additional 2 years beyond the charter officials on specific complex scientific and combination products. Members VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1

Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 47397 will be invited to serve for overlapping recommends sponsors provide to of New Animal Drugs used in Food- terms of up to 4 years. Almost all non- address the human food safety of new Producing Animals.’’ Received Federal members of this committee animal drugs used in food-producing comments will be placed in the docket serve as Special Government animals. and, except for those submitted as Employees. The core of voting members DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly may include one technically qualified any guidance at any time (see 21 CFR viewable at http://www.regulations.gov member, selected by the Commissioner 10.115(g)(5)), to ensure that the Agency or at the Division of Dockets or designee, who is identified with considers your comment on this draft Management between 9 a.m. and 4 p.m., consumer interests and is recommended guidance before it begins work on the Monday through Friday. by either a consortium of consumer- final version of the guidance, submit • Confidential Submissions—To oriented organizations or other submit a comment with confidential either electronic or written comments interested persons. The Committee may information that you do not wish to be on the draft guidance by September 19, also include technically qualified made publicly available, submit your 2016. federal members. comments only as a written/paper Further information regarding the ADDRESSES: You may submit comments submission. You should submit two most recent charter and other as follows: copies total. One copy will include the information can be found at http:// Electronic Submissions information you claim to be confidential www.fda.gov/AdvisoryCommittees/ with a heading or cover note that states CommitteesMeetingMaterials/ Submit electronic comments in the following way: ‘‘THIS DOCUMENT CONTAINS ScienceBoardtotheFoodand CONFIDENTIAL INFORMATION.’’ The DrugAdministration/ucm115356.htm or • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the Agency will review this copy, including by contacting the Designated Federal the claimed confidential information, in Officer (see FOR FURTHER INFORMATION instructions for submitting comments. Comments submitted electronically, its consideration of comments. The CONTACT). In light of the fact that no second copy, which will have the change has been made to the committee including attachments, to http:// www.regulations.gov will be posted to claimed confidential information name or description of duties, no redacted/blacked out, will be available amendment will be made to 21 CFR the docket unchanged. Because your comment will be made public, you are for public viewing and posted on http:// 14.100. www.regulations.gov. Submit both This document is issued under the solely responsible for ensuring that your comment does not include any copies to the Division of Dockets Federal Advisory Committee Act (5 Management. If you do not wish your U.S.C. app.). For general information confidential information that you or a third party may not wish to be posted, name and contact information to be related to FDA advisory committees, made publicly available, you can please visit us at http://www.fda.gov/ such as medical information, your or anyone else’s Social Security number, or provide this information on the cover AdvisoryCommittees/default.htm. sheet and not in the body of your confidential business information, such Dated: July 15, 2016. comments and you must identify this as a manufacturing process. Please note Leslie Kux, information as ‘‘confidential.’’ Any that if you include your name, contact Associate Commissioner for Policy. information, or other information that information marked as ‘‘confidential’’ [FR Doc. 2016–17182 Filed 7–20–16; 8:45 am] identifies you in the body of your will not be disclosed except in BILLING CODE 4164–01–P comments, that information will be accordance with 21 CFR 10.20 and other posted on http://www.regulations.gov. applicable disclosure law. For more • If you want to submit a comment information about FDA’s posting of DEPARTMENT OF HEALTH AND with confidential information that you comments to public dockets, see 80 FR HUMAN SERVICES do not wish to be made available to the 56469, September 18, 2015, or access public, submit the comment as a the information at: http://www.fda.gov/ Food and Drug Administration regulatoryinformation/dockets/ written/paper submission and in the [Docket No. FDA–2005–D–0155 (formerly manner detailed (see ‘‘Written/Paper default.htm. 2005D–0219)] Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to read background documents or the General Principles for Evaluating the Written/Paper Submissions electronic and written/paper comments Human Food Safety of New Animal Submit written/paper submissions as received, go to http:// Drugs Used in Food-Producing follows: www.regulations.gov and insert the Animals; Draft Guidance for Industry; • Mail/Hand delivery/Courier (for docket number, found in brackets in the Availability written/paper submissions): Division of heading of this document, into the AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts HHS. and Drug Administration, 5630 Fishers and/or go to the Division of Dockets ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. • For written/paper comments 1061, Rockville, MD 20852. SUMMARY: The Food and Drug submitted to the Division of Dockets Submit written requests for single Administration (FDA or Agency) is Management, FDA will post your copies of the draft guidance to the announcing the availability of a draft comment, as well as any attachments, Policy and Regulations Staff (HFV–6), asabaliauskas on DSK3SPTVN1PROD with NOTICES revised guidance for industry #3 except for information submitted, Center for Veterinary Medicine, Food entitled ‘‘General Principles for marked and identified, as confidential, and Drug Administration, 7519 Standish Evaluating the Human Food Safety of if submitted as detailed in Pl., Rockville, MD 20855. Send one self- New Animal Drugs Used in Food- ‘‘Instructions.’’ addressed adhesive label to assist that Producing Animals.’’ This draft revised Instructions: All submissions received office in processing your requests. See guidance describes the type of must include the Docket No. FDA– the SUPPLEMENTARY INFORMATION section information that FDA’s Center for 2005–D–0155 for ‘‘General Principles for electronic access to the draft Veterinary Medicine (CVM) for Evaluating the Human Food Safety guidance document. VerDate Sep<11>2014 17:15 Jul 20, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1


Document Created: 2018-02-08 07:59:09
Document Modified: 2018-02-08 07:59:09
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
ActionNotice; renewal of advisory committee.
DatesAuthority 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.
ContactRakesh 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, [email protected]
FR Citation81 FR 47396 
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