40846 Federal Register / Vol. 87, No. 130 / Friday, July 8, 2022 / Notices 

in non-tribal HPOG programs and will 

include a cost-benefit analysis. Key 

participant outcomes of interest include 

(but are not limited to) educational 

progress, employment, and earnings. 

The HPOG 2.0 Long-Term Follow-Up 

Study will use survey and 

administrative data to estimate longerterm (approximately 51⁄2 years after 

random assignment) program impacts at 

the local and national level and to 

explore characteristics of local programs 

that are associated with more favorable 

outcomes. By extending data collection 

to include an LTS, OPRE can address 

important unanswered questions for 

policymakers and practitioners. The 

HPOG 2.0 LTS specifically will provide 

insights into the long-term impacts of 

HPOG 2.0 for outcomes that are not 

captured in administrative records, such 

as details about educational 

experiences, characteristics of 

employment, self-employment, and 

earnings from jobs not covered in 

administrative data, receipt of public 

assistance, physical and mental wellbeing, and child outcomes. There are 

two versions of the HPOG 2.0 LTS, the 

full version (Instrument 21) and a 

shorter version with critical items of 

interest only (Instrument 21a). 

Instrument 21a will be offered to 

reluctant participants who would 

otherwise not complete the survey to 

help maximize response rates and 

reduce item non-response for the most 

critical outcomes in the study. 

Respondents: HPOG 2.0 impact study 

participants from the 27 non-tribal 

HPOG 2.0 grantees (treatment and 

control group members) who enrolled 

between September 2017 and January 

2018. 

Annual Burden Estimates: This 

request is specific to the HPOG 2.0 

Long-Term Follow-Up Survey (LTS) 

(both the full and critical items only 

versions). Currently approved materials 

and associated burden, which we plan 

to continue to use can be found at: 

https://www.reginfo.gov/public/do/ 

PRAICList?ref_nbr=201904-0970-006. 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Annual burden 

(in hours) 

Instrument 21a: HPOG 2.0 Long-Term Survey ................... 3,064 1 1 3,064 1,021 

Instrument 21a: HPOG 2.0 Long-Term Survey Critical 

Items Instrument ............................................................... 541 1 0.33 179 60 

Total .............................................................................. 3,605 ........................ ........................ 3,243 1,081 

Estimated Total Annual Burden 

Hours: 1,081. 

Authority: Section 2008 of the Social 

Security Act as enacted by section 5507 

of the Affordable Care Act and section 

413 of the Social Security Act, 42 U.S.C. 

613. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–14580 Filed 7–7–22; 8:45 am] 

BILLING CODE 4184–72–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–0388] 

Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry #245 entitled 

‘‘Hazard Analysis and Risk-Based 

Preventive Controls for Food for 

Animals.’’ This final guidance 

document is intended to 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.’’ The 

guidance announced in this notice 

finalizes the draft guidance of the same 

title dated January 23, 2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 8, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2018–D–0388 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 


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Federal Register / Vol. 87, No. 130 / Friday, July 8, 2022 / Notices 40847 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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 guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Erickson, Center for Veterinary 

Medicine (HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–7382, 

Jennifer.erickson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 23, 

2018 (83 FR 3163) and a correction in 

the Federal Register of February 5, 2018 

(83 FR 5106), FDA published the notice 

of availability for a draft guidance #245 

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

Animals,’’ giving interested persons 

until July 23, 2018, to comment on the 

draft guidance. FDA received numerous 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. We have made 

some changes and updates. First, we 

removed Appendix E: ‘‘Aid to 

Identifying Animal Food Hazards’’ 

based on comments questioning how it 

should be used and concerns about how 

to distinguish whether a listed hazard is 

known or reasonably foreseeable for a 

facility, specific ingredient, or type of 

animal food. Second, we provided 

additional clarity, based on comments, 

that not all the known or reasonably 

foreseeable hazard examples in the 

guidance are applicable to all animal 

food. Third, we included additional 

examples of certain hazards in animal 

food, preventive controls, and situations 

that would require a reanalysis of a food 

safety plan. Fourth, we updated some of 

the references used throughout the 

guidance. Lastly, editorial and 

formatting changes were made to 

improve clarity and consistency. The 

guidance announced in this notice 

finalizes the draft guidance dated 

January 23, 2018. 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘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. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 507 have 

been approved under OMB Control No. 

0910–0751. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: June 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14567 Filed 7–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–1909; FDA– 

2020–E–1906; FDA–2020–E–1901; FDA– 

2020–E–1899] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PADCEV 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for PADCEV and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human 

biological product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 6, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 4, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 


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