Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46497 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section; activity Number of 

respondents 

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.

1 1 1 4 ...................................... 4 

507.85(b); requests for reinstatement of exemption ........................................... 1 1 1 2 ...................................... 2 

Total .............................................................................................................. .................... .................... .................... ......................................... 286 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Subpart A—General Provisions 

507.7(e); records attesting that the facility is a ‘‘qualified’’ facility ...................... 1,120 0.5 560 0.1 (6 minutes) ............... 56 

507.4(d); documentation of animal food safety and hygiene training ................. 7,469 0.75 5,579 0.05 (3 minutes) ............. 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 

Subpart E—Supply-Chain Program 

507.105 through 507.175; written supply-chain program—including records 

documenting program.

7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 

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 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per disclosure Total hours 

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.

330 10 3,300 0.25 (15 minutes) ........... 825 

507.7(e)(1); change labels on products with labels ............................................ 1,526 4 6,104 1 ...................................... 6,104 

507.7(e)(2); change address on labeling (sales documents) for qualified facilities.1,329 1 1,329 1 ...................................... 1,329 

507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified.330 312 102,960 0.01 (36 seconds) .......... 1,030 

507.28(b); holding and distribution of human food byproducts for use as animal food.40,798 2 81,596 0.25 (15 minutes) ........... 20,399 

Total .............................................................................................................. .................... .................... .................... ......................................... 29,687 

1There 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 

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. 

[FR Doc. 2018–19909 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–2018–N–3381] 

Science Board to the Food and Drug 

Administration Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 


daltland on DSKBBV9HB2PROD with NOTICES
46498 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

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/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 

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/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. 

SUMMARY: 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 


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