81930 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that IMCIVREE (setmelanotide) 

injection, manufactured by Rhythm 

Pharmaceuticals, Inc., meets the criteria 

for a priority review voucher. IMCIVREE 

(setmelanotide) injection is indicated for 

the treatment of chronic weight 

management in adult and pediatric 

patients 6 years of age and older with 

proopiomelanocortin (POMC), 

proprotein convertase subtilisin/kexin 

type 1 (PCSK1), or leptin receptor 

(LEPR) deficiency obesity confirmed by 

genetic testing demonstrating variants in 

POMC, PCSK1, or LEPR genes that are 

interpreted as pathogenic, likely 

pathogenic, or of uncertain significance. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about IMCIVREE 

(setmelanotide) injection, go to the 

‘‘Drugs@FDA’’ website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: December 14, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27760 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0520] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the recordkeeping 

requirements for substances prohibited 

from use in animal food or feed. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 16, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 16, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 16, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2013–N–0520 for ‘‘Substances 

Prohibited From Use in Animal Food or 

Feed.’’ Received comments, those filed 

in a timely manner (see ADDRESSES), 

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, 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. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 81931 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Substances Prohibited From Use in 

Animal Food or Feed—21 CFR Part 589 

OMB Control Number 0910–0627— 

Extension 

This information collection supports 

Agency regulations regarding substances 

prohibited from use in animal food or 

feed. Bovine spongiform 

encephalopathy (BSE) is a progressive 

and fatal neurological disorder of cattle 

that results from an unconventional 

transmissible agent. BSE belongs to the 

family of diseases known as 

transmissible spongiform 

encephalopathies (TSEs). All TSEs 

affect the central nervous system of 

infected animals. Our regulation at 

§ 589.2001 (21 CFR 589.2001), entitled 

‘‘Cattle materials prohibited in animal 

food or feed to prevent the transmission 

of bovine spongiform encephalopathy,’’ 

is designed to further strengthen 

existing safeguards against the 

establishment and amplification of BSE 

in the United States through animal 

feed. The regulation prohibits the use of 

certain cattle origin materials in the 

food or feed of all animals. These 

materials are referred to as ‘‘cattle 

materials prohibited in animal feed’’ or 

CMPAF. Under § 589.2001, no animal 

feed or feed ingredient can contain 

CMPAF. As a result, we impose 

requirements on renderers of 

specifically defined cattle materials, 

including reporting and recordkeeping 

requirements. For purposes of the 

regulation, we define a renderer as any 

firm or individual that processes 

slaughter byproducts; animals unfit for 

human consumption, including 

carcasses of dead cattle; or meat scraps. 

Reporting and recordkeeping 

requirements are necessary because 

once materials are separated from an 

animal it may not be possible, without 

records, to know whether the cattle 

material meets the requirements of our 

regulation. 

Reporting: Under our regulations, we 

may designate a country from which 

cattle materials are not considered 

CMPAF. Section 589.2001(f) provides 

that a country seeking to be so 

designated must send a written request 

to the Director of the Center for 

Veterinary Medicine. The country is 

required to submit information about its 

BSE case history, risk factors, measures 

to prevent the introduction and 

transmission of BSE, and any other 

information relevant to determining 

whether the cattle materials from the 

requesting country do or do not meet 

the definitions set forth in 

§ 589.2001(b)(1). We use the 

information to determine whether to 

grant a request for designation and to 

impose conditions if a request is 

granted. Section 589.2001(f) further 

states that countries designated under 

that section will be subject to our future 

review to determine whether their 

designations remain appropriate. As 

part of this process, we may ask 

designated countries from time to time 

to confirm that their BSE situation and 

the information submitted by them in 

support of their original application 

remains unchanged. We may revoke a 

country’s designation if we determine 

that it is no longer appropriate. 

Therefore, designated countries may 

respond to our periodic requests by 

submitting information to confirm their 

designations remain appropriate. We 

use the information to ensure their 

designations remain appropriate. 

Recordkeeping: Renderers that 

receive, manufacture, process, blend, or 

distribute CMPAF, or products that 

contain or may contain CMPAF, must 

take measures to ensure that the 

materials are not introduced into animal 

feed, including maintaining adequate 

written procedures specifying how such 

processes are to be carried out 

(§ 589.2001(c)(2)(ii)). Renderers that 

receive, manufacture, process, blend, or 

distribute CMPAF are required to 

establish and maintain records 

sufficient to track the CMPAF to ensure 

that they are not introduced into animal 

feed (§ 589.2001(c)(2)(vi)). 

Renderers that receive, manufacture, 

process, blend, or distribute any cattle 

materials must establish and maintain 

records sufficient to demonstrate that 

material rendered for use in animal feed 

was not manufactured from, processed 

with, or does not otherwise contain, 

CMPAF (§ 589.2001(c)(3)(i)). 

Renderers that receive, manufacture, 

process, blend, or distribute any cattle 

materials must, if these materials were 

obtained from an establishment that 

segregates CMPAF from other materials, 

establish and maintain records to 

demonstrate that the supplier has 

adequate procedures in place to 

effectively exclude CMPAF from any 

materials supplied (§ 589.2001(c)(3)(i)). 

Records will meet this requirement if 

they include either: (1) Certification or 

other documentation from the supplier 

that materials supplied do not include 

CMPAF (§ 589.2001(c)(3)(i)(A)), or (2) 

documentation of another method 

acceptable to FDA, such as third-party 

certification (§ 589.2001(c)(3)(i)(B)). 

Description of Respondents: 

Respondents to this information 

collection include rendering facilities, 

feed manufacturers, livestock feeders, 

and foreign governments seeking 

designation under § 589.2001(f). 

FDA estimates the burden of this 

collection of information as follows: 

81932 Federal Register / Vol. 85, No. 243 / Thursday, December 17, 2020 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

589.2001(f); request for designation .................................... 1 1 1 80 80 

589.2001(f); response to request for review by FDA .......... 1 1 1 26 26 

Total .............................................................................. ........................ ........................ ........................ ........................ 106 

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 part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

589.2001(c)(2)(ii); maintain written procedures ................... 50 1 50 20 1,000 

589.2001(c)(2)(vi) and (c)(3)(i); maintain records ............... 175 1 175 20 3,500 

589.2001(c)(3)(i)(A) and (B); certification or documentation 

from the supplier .............................................................. 175 1 175 26 4,550 

Total .............................................................................. ........................ ........................ ........................ ........................ 9,050 

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

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: December 9, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27746 Filed 12–16–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0074] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; State Enforcement 

Notifications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on reporting 

requirements contained in existing FDA 

regulations governing State enforcement 

notifications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 16, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 16, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 16, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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–N–0074 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; State 

Enforcement Notifications.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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, 202–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be