Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3163 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2343] 

Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a draft 

guidance for industry #245 entitled 

‘‘Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals.’’ This draft guidance 

document, when finalized, will help 

animal food facilities comply with the 

requirements for hazard analysis and 

risk-based preventive controls under our 

regulation ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals.’’ 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 23, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2016–D–2343 for ‘‘Hazard Analysis and 

Risk-Based Preventive Controls for Food 

for Animals.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 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. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Murphy, Center for Veterinary 

Medicine (HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–6246, 

jenny.murphy@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Food Safety Modernization 

Act (FSMA) (Pub. L. 111–353) enables 

FDA to better protect public (human 

and animal) health by helping to ensure 

the safety and security of the food 

supply. FSMA enables FDA to focus 

more on preventing animal food safety 

problems rather than relying primarily 

on reacting to problems after they occur. 

Section 103 of FSMA amended the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), by adding section 418 (21 

U.S.C. 350g) with requirements for 

hazard analysis and risk-based 

preventive controls for establishments 

that are required to register as food 

facilities under our regulations in 21 

CFR part 1, subpart H, in accordance 

with section 415 of the FD&C Act (21 

U.S.C. 350d). We have established 

regulations to implement the hazard 

analysis and risk-based preventive 

controls requirements within part 507 

(21 CFR part 507). 

We are announcing the availability of 

a draft guidance for industry #245 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Food for 

Animals.’’ This multi-chapter draft 

guidance for industry is intended to 


sradovich on DSK3GMQ082PROD with NOTICES
3164 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 

explain how to comply with the 

requirements for hazard analysis and 

risk-based preventive controls for food 

for animals under part 507. The 

chapters we are announcing in this 

document are as follows: 

• Introduction 

• Chapter One—The Food Safety Plan 

• Chapter Two—Conducting a Hazard 

Analysis 

• Chapter Three—Hazards Associated 

with the Manufacturing, Processing, 

Packing, and Holding of Animal Food 

• Chapter Four—Preventive Controls 

• Chapter Five—Overview of 

Preventive Control Management 

Components 

We intend to announce the 

availability for public comment of 

additional chapters of the draft guidance 

as we complete them. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on how to comply with 

the hazard analysis and risk-based 

preventive controls requirements for the 

regulation ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Food for Animals.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in part 507 have been 

approved under OMB control number 

0910–0789. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: January 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–01126 Filed 1–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–6702] 

The Least Burdensome Provisions: 

Concept and Principles; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; extension 

of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

notice of availability that appeared in 

the Federal Register of December 15, 

2017. In the notice of availability, FDA 

requested comments on the draft 

guidance for industry and FDA staff 

entitled ‘‘The Least Burdensome 

Provisions: Concept and Principles.’’ 

The Agency is taking this action in 

response to a request for an extension to 

allow interested persons additional time 

to submit comments. 

DATES: FDA is extending the comment 

period on the document published 

December 15, 2017 (82 FR 59623), by an 

additional 30 days. Submit either 

electronic or written comments on the 

draft guidance by March 15, 2018, to 

ensure that the Agency considers your 

comment on this draft guidance before 

it begins work on the final version of the 

guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–D–6702 for ‘‘The Least 

Burdensome Provisions: Concept and 

Principles; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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 


sradovich on DSK3GMQ082PROD with NOTICES