Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting, 46497-46498 [2018-19906]

Download as PDF Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46497 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of respondents 21 CFR section; activity Number of responses per respondent Total annual responses Average burden per response Total hours 507.67, 507.69, and 507.71; submission of an appeal, including submission of a request for an informal hearing. 507.85(b); requests for reinstatement of exemption ........................................... 1 1 1 4 ...................................... 4 1 1 1 2 ...................................... 2 Total .............................................................................................................. .................... .................... .................... ......................................... 286 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR section; activity Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Subpart A—General Provisions 507.7(e); records attesting that the facility is a ‘‘qualified’’ facility ...................... 507.4(d); documentation of animal food safety and hygiene training ................. 1,120 7,469 0.5 0.75 560 5,579 0.1 (6 minutes) ............... 0.05 (3 minutes) ............. 56 279 Subpart C—Hazard Analysis and Risk-Based Preventive Controls 507.31 through 507.55; food safety plan—including hazard analysis, preventive controls, monitoring, corrective actions, verification, validation reanalysis, modifications, and implementation records. 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 519 3,876,411 0.1 (6 minutes) ............... 387,641 Subpart E—Supply-Chain Program 507.105 through 507.175; written supply-chain program—including records documenting program. 7,469 Subpart F—Requirements Applying to Records 507.200 through 507.215; general requirements, additional requirements applying to food safety plan, requirements for record retention, use of existing records, and special requirements applicable to written assurance. 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 Totals ............................................................................................................ .................... .................... 11,635,372 ......................................... 1,163,258 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR section; activity 507.27(b); labeling for the animal food product contains the specific information and instructions needed so the food can be safely used for the intended animal species. 507.7(e)(1); change labels on products with labels ............................................ 507.7(e)(2); change address on labeling (sales documents) for qualified facilities. 507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified. 507.28(b); holding and distribution of human food byproducts for use as animal food. Total .............................................................................................................. daltland on DSKBBV9HB2PROD with NOTICES 1 There Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 330 10 3,300 0.25 (15 minutes) ........... 825 1,526 1,329 4 1 6,104 1,329 1 ...................................... 1 ...................................... 6,104 1,329 330 312 102,960 0.01 (36 seconds) .......... 1,030 40,798 2 81,596 0.25 (15 minutes) ........... 20,399 .................... .................... .................... ......................................... 29,687 are no capital costs or operating and maintenance costs associated with this collection of information. As previously stated, we retain the currently approved burden estimate for the information collection. These figures are based on our regulatory impact analysis in support of the final rule on Preventive Controls for Food for Animals, which published in the Federal Register of September 17, 2015 (80 FR 56170). Using Agency data, we estimated the number of animal food facilities that we believe are subject to the regulations. We base our estimate of VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 the time necessary for the individual reporting, recordkeeping, and thirdparty disclosure activities on our experience with similar information collections. Dated: September 7, 2018. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3381] [FR Doc. 2018–19909 Filed 9–12–18; 8:45 am] Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting BILLING CODE 4164–01–P AGENCY: PO 00000 Food and Drug Administration, HHS. Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1 46498 ACTION: Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs 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 provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, 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 meeting will be open to the public. DATES: The meeting will be held on October 22, 2018, from 8:30 a.m. to 4:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, MD 20993. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https://collaboration. fda.gov/scienceboard2018/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301–796–4769, rakesh.raghuwanshi@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The Science Board will hear a response from the Center for Veterinary Medicine (CVM) to the recommendations made by the Science Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System program. The Science Board will also discuss potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 15, 2018. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 5, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 9, 2018. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 disability, please contact Rakesh Raghuwanshi at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19906 Filed 9–12–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1984] Request for Nominations on the Tobacco Products Scientific Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice. DATES: Any small business tobacco manufacturing industry organization interested in participating in the selection of appropriate nonvoting members to represent industry interests SUMMARY: E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46497-46498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3381]


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

[[Page 46498]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Board to the Food and 
Drug Administration. The Science Board provides advice to the 
Commissioner of Food and Drugs 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 provides advice to the Agency on 
keeping pace with technical and scientific developments including in 
regulatory science, 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 meeting will be open to the public.

DATES: The meeting will be held on October 22, 2018, from 8:30 a.m. to 
4:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, 
MD 20993. For those unable to attend in person, the meeting will also 
be webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard2018/. Answers to commonly asked 
questions including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver 
Spring, MD 20993, 301-796-4769, [email protected], or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's website 
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down 
to the appropriate advisory committee meeting link, or call the 
advisory committee information line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The Science Board will hear a response from the Center for 
Veterinary Medicine (CVM) to the recommendations made by the Science 
Board's 2017 review of CVM's National Antibiotic Resistance Monitoring 
System program. The Science Board will also discuss potential hazards 
and nutritional considerations in the production of food derived from 
animal cell culture technologies.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
October 15, 2018. Oral presentations from the public will be scheduled 
between approximately 3:30 p.m. and 4:30 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before October 5, 2018. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by October 9, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Rakesh Raghuwanshi at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19906 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P

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