46496 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

responses. We calculate a reporting 

burden of 120 hours per response, for a 

total burden of 1,440 hours. We estimate 

42 respondents will submit 2 Category 

D submissions annually, for a total of 84 

responses. We calculate a reporting 

burden of 150 hours per response, for a 

total burden of 12,600 hours. We 

estimate 38 respondents will submit 1 

Category E submission annually, for a 

total of 38 responses. We calculate a 

reporting burden of 150 hours per 

response, for a total burden of 5,700 

hours. 

In row 6, we estimate 190 respondents 

will submit information to a prenotification consultation or a master file 

in support of FCN submission using 

Form FDA 3480. We calculate a 

reporting burden of 0.5 hours per 

response, for a total burden of 95 hours. 

In row 7 we estimate 100 respondents 

will submit an amendment (Form FDA 

3480A) to a substantive or nonsubstantive request of additional 

information to an incomplete FCN 

submission, an amendment to a prenotification consultation, or an 

amendment to a master file in support 

of an FCN. We calculate a reporting 

burden of 0.5 hours per response, for a 

total burden of 50 hours. 

In row 8, we estimate one respondent 

will submit one indirect food additive 

petition under § 171.1, for a total of one 

response. We calculate a reporting 

burden of 10,995 hours per response, for 

a total burden of 10,995 hours. 

In row 9, we estimate 10 respondents 

will utilize the recommendations in the 

guidance document entitled, ‘‘Use of 

Recycled Plastics in Food Packaging: 

Chemistry Considerations,’’ to develop 

the additional information for one such 

submission annually, for a total of 10 

responses. We calculate a reporting 

burden of 25 hours per response, for a 

total burden of 250 hours. 

Finally, in row 10, we estimate 2 

respondents will utilize the 

recommendations in the draft guidance, 

once finalized, entitled, ‘‘Preparation of 

Food Contact Notifications for Food 

Contact Substances in Contact with 

Infant Formula and/or Human Milk,’’ to 

develop the additional information for 

one such submission annually, for a 

total of 2 responses. We calculate a 

reporting burden of 5 hours per 

response, for a total burden of 10 hours. 

Dated: September 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19898 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–1857] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 15, 

2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0789. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Current Good Manufacturing Practice 

and Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals—21 CFR Part 507 

OMB Control Number 0910–0789— 

Extension 

The information collection supports 

FDA regulations. As amended by the 

FDA Food Safety Modernization Act 

(FSMA) (Pub. L. 111–353), the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) enables the Agency to better protect 

the public health by helping to ensure 

the safety and security of the food 

supply. It enables FDA to focus more on 

preventing food safety problems rather 

than relying primarily on reacting to 

problems after they occur. FSMA 

recognizes the important role industry 

plays in ensuring the safety of the food 

supply, including the adoption of 

modern systems of preventive controls 

in food production. Specifically, section 

418 (21 U.S.C. 350g) of the FD&C Act 

sets forth requirements for hazard 

analysis and risk-based preventive 

controls for facilities that produce food 

for animals. To implement these 

provisions, regulations were codified 

under 21 CFR part 507—Current Good 

Manufacturing Practice, Hazard 

Analysis, And Risk-Based Preventive 

Controls For Food For Animals. The 

regulations establish requirements for a 

written food safety plan; hazard analysis 

preventive controls; monitoring; 

corrective actions and corrections; 

verification; supply-chain program; 

recall plan; and associated records and 

became effective November 16, 2015. 

Currently, we continue to evaluate 

burden associated with the information 

collection requirements however, for 

purposes of extending the information 

collection we retain the currently 

approved figures as shown in the 

following tables. 

In the Federal Register of May 24, 

2018 (83 FR 24124), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received three 

comments, however none pertained to 

the information collection or underlying 

regulations. 

We estimate our burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per response Total hours 

507.7 exemption: submit attestation of preventive controls or compliance with 

State and local laws (non-federal).

1,120 0.5 560 0.5 (30 minutes) ............. 280 


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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