Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 47501 

in support of the service referral 

responsibilities of the State Refugee 

Coordinators. Similar information for 

ORR’s discretionary grants is currently 

made public. 

DATES: Comments due within 30 days of 

publication. The Office of Management 

and Budget (OMB) is required to make 

a decision concerning the collection of 

information between 30 and 60 days 

after publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: This data collection 

requests RSS grantees and RSS Set 

Aside grantees to provide the agency 

name, city, state, website, and funding 

amount for each contracted sub-grantee. 

The information will be used for 

national resource mapping pertaining to 

ORR RSS funding at the local level. 

Improved knowledge of all local 

providers is important to ORR’s overall 

oversight of the program. In addition to 

RSS formula funding to states and state 

replacement agencies who then issue 

sub-awards to local providers, ORR also 

awards discretionary grants that directly 

fund local refugee service providers. 

This report will provide ORR a 

complete picture of the availability all 

ORR resources to assist newly arrived 

refugees at the local level increasing our 

ability to identify gaps or target areas of 

need. 

Respondents: State governments and 

replacement designees. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden hours 

Annual 

burden hours 

RSS and RSS Set Aside Sub-grantee List ......................... 56 3 2 336 112 

Estimated Total Annual Burden 

Hours: 112. 

Authority: Refugee Act of 1980 

[Immigration and Nationality Act, Title 

IV, Chapter 2 Section 412(e)] and 45 

CFR 400.28. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–18307 Filed 8–24–21; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Environmental 

Impact Considerations 

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 ‘‘Environmental 

Impact Considerations.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 25, 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 October 25, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of October 25, 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– 

2012–N–0961 for ‘‘Environmental 

Impact Considerations.’’ 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. 


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47502 Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 

• 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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. 

Environmental Impact Considerations 

OMB Control Number 0910–0322— 

Extension 

I. Background 

FDA is requesting OMB approval for 

the reporting requirements contained in 

the FDA collection of information 

‘‘Environmental Impact 

Considerations.’’ The National 

Environmental Policy Act (NEPA) (42 

U.S.C. 4321–4347) states national 

environmental objectives and imposes 

upon each Federal Agency the duty to 

consider the environmental effects of its 

actions. Section 102(2)(C) of NEPA 

requires the preparation of an 

environmental impact statement (EIS) 

for every major Federal action that will 

significantly affect the quality of the 

human environment. 

FDA’s NEPA regulations are in part 25 

(21 CFR part 25). All applications or 

petitions requesting Agency action 

require the submission of a claim for 

categorical exclusion or an 

environmental assessment (EA). A 

categorical exclusion applies to certain 

classes of FDA-regulated actions that 

usually have little or no potential to 

cause significant environmental effects 

and are excluded from the requirements 

to prepare an EA or EIS. In § 25.15(a) 

and (d) (21 CFR 25.15(a) and (d)) the 

procedures for submitting to FDA a 

claim for a categorical exclusion are 

specified. Extraordinary circumstances 

(under 21 CFR 25.21), which may result 

in significant environmental impacts, 

may exist for some actions that are 

usually categorically excluded. An EA 

provides information that is used to 

determine whether an FDA action could 

result in a significant environmental 

impact. Section 25.40(a) and (c) (21 CFR 

25.40(a) and (c)) specifies the content 

requirements for EAs for non-excluded 

actions. 

This collection of information is used 

by FDA to assess the environmental 

impact of Agency actions and to ensure 

that the public is informed of 

environmental analyses. Firms wishing 

to manufacture and market substances 

regulated under statutes for which FDA 

is responsible must, in most instances, 

submit applications requesting 

approval. Environmental information 

must be included in such applications 

for the purpose of determining whether 

the proposed action may have a 

significant impact on the environment. 

Where significant adverse events cannot 

be avoided, the Agency uses the 

submitted information as the basis for 

preparing and circulating to the public 

an EIS, made available through a 

Federal Register document also filed for 

comment at the Environmental 

Protection Agency. The final EIS, 

including the comments received, is 

reviewed by the Agency to weigh 

environmental costs and benefits in 

determining whether to pursue the 

proposed action or some alternative that 

would reduce expected environmental 

impact. 

Any final EIS would contain 

additional information gathered by the 

Agency after the publication of the draft 

EIS, a copy or a summary of the 

comments received on the draft EIS, and 

the Agency’s responses to the 

comments, including any revisions 

resulting from the comments or other 

information. When the Agency finds 

that no significant environmental effects 

are expected, the Agency prepares a 

finding of no significant impact. 

FDA estimates the burden of this 

collection of information as follows: 

II. Estimated Annual Reporting Burden 

for Human Drugs (Including Biologics 

in the Center for Drug Evaluation and 

Research) 

Under §§ 312.23(a)(7)(iv)(e), 

314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 

CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), 

and 314.94(a)(9)(i)), each investigational 

new drug application (IND), new drug 

application (NDA), and abbreviated new 

drug application (ANDA) must contain 

a claim for categorical exclusion under 

§ 25.30 (21 CFR 25.30) or § 25.31 (21 

CFR 25.31), or an EA under § 25.40. 

Annually, FDA receives approximately 


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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 47503 

5,503 INDs from 3,717 sponsors; 142 

NDAs from 111 applicants; 3,285 

supplements to NDAs from 516 

applicants; 35 biologic license 

applications (BLAs) from 32 applicants; 

777 supplements to BLAs from 89 

applicants; 743 ANDAs from 239 

applicants; and 11,438 supplements to 

ANDAs from 482 applicants. FDA 

estimates that it receives approximately 

21,923 claims for categorical exclusions 

as required under § 25.15(a) and (d) and 

13 EAs as required under § 25.40(a) and 

(c). Based on information provided by 

the pharmaceutical industry, FDA 

estimates that it takes sponsors or 

applicants approximately 8 hours to 

prepare a claim for a categorical 

exclusion and approximately 3,400 

hours to prepare an EA. Based on recent 

numbers, we now estimate a total of 

21,936 annual responses and 219,584 

hours for human drugs (an increase of 

6,489 responses and 62,088 hours). 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and(d) .................................................................... 5,186 4.2273 21,923 8 175,384 

25.40(a) and (c) ................................................................... 14 0.9285 13 3,400 44,200 

Total .............................................................................. ........................ ........................ ........................ ........................ 219,584 

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

III. Estimated Annual Reporting 

Burden for Medical Devices 

Under § 814.20(b)(11) (21 CFR 

814.20(b)(11)), premarket approval 

applications (PMAs) (original PMAs and 

supplements) must contain a claim for 

categorical exclusion under § 25.30 or 

§ 25.34 (21 CFR 25.34) or an EA under 

§ 25.40. In 2020, FDA received an 

average of 62 claims (original PMAs and 

supplements) for categorical exclusions 

as required under § 25.15(a) and (d), and 

0 EAs as required under § 25.40(a) and 

(c). FDA estimates that approximately 

62 respondents will submit an average 

of 1 application for categorical 

exclusion annually. Based on 

information provided by sponsors, FDA 

estimates that it takes approximately 6 

hours to prepare a claim for a 

categorical exclusion. Based on recent 

numbers, we now estimate a total of 62 

annual responses and 372 hours for 

medical devices (an increase of 12 

responses and 72 hours). 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 62 1 62 6 372 

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

IV. Estimated Annual Reporting Burden 

for Biological Products, Drugs, and 

Medical Devices in the Center for 

Biologics Evaluation and Research 

Under 21 CFR 601.2(a), BLAs as well 

as INDs (§ 312.23), NDAs (§ 314.50), 

ANDAs (§ 314.94), and PMAs (§ 814.20) 

must contain either a claim of 

categorical exclusion under § 25.30 or 

§ 25.32 (21 CFR 25.32) or an EA under 

§ 25.40. Annually, FDA receives 

approximately 11 BLAs from 11 

applicants, 1,080 BLA supplements to 

license applications from 160 

applicants, 7,017 INDs from 2,087 

sponsors, 1 NDA from 1 applicant, 16 

supplements to NDAs from 6 applicants, 

1 ANDA from 1 applicant, 3 

supplements to ANDAs from 2 

applicants, 1 PMA from 1 applicant, and 

79 PMA supplements from 19 

applicants. FDA estimates that 

approximately 10 percent of these 

supplements would be submitted with a 

claim for categorical exclusion or an EA. 

FDA estimates that it has received 

approximately 7,150 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d) annually and 4 EAs as 

required under § 25.40(a) and (c) 

annually. Therefore, FDA estimates that 

approximately 3,575 respondents will 

submit an average of 2 applications for 

categorical exclusion, and 4 respondents 

will submit an average of 1 EA. Based 

on information provided by industry, 

FDA estimates that it takes sponsors and 

applicants approximately 8 hours to 

prepare a claim of categorical exclusion 

and approximately 3,400 hours to 

prepare an EA for a biological product. 

Based on recent numbers, we now 

estimate a total of 7,154 annual 

responses and 70,800 hours for 

biological products (an increase of 6,658 

responses and 60,048 hours). 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 3,575 2 7,150 8 57,200 

25.40(a) and(c) .................................................................... 4 1 4 3,400 13,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 70,800 

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


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V. Estimated Annual Reporting Burden 

for Animal Drugs 

Under 21 CFR 514.1(b)(14), new 

animal drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs); supplemental 

NADAs and ANADAs (21 CFR 

514.8(a)(1)); investigational new animal 

drug applications (INADs) and generic 

investigational new animal drug 

applications (JINADs) (21 CFR 

511.1(b)(10)); and food additive 

petitions (21 CFR 571.1(c)) must contain 

a claim for categorical exclusion under 

§ 25.30 or § 25.32 or an EA under 

§ 25.40. Annually, FDA’s Center for 

Veterinary Medicine has received 

approximately 1,140 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d) and 9 EAs as required 

under § 25.40(a) and (c). Assuming an 

average of 10 claims per respondent, 

FDA estimates that approximately 114 

respondents will submit an average of 

10 claims for categorical exclusion. FDA 

further estimates that nine respondents 

will submit an average of one EA. FDA 

estimates that it takes sponsors/ 

applicants approximately 3 hours to 

prepare a claim of categorical exclusion 

and an average of 2,160 hours to prepare 

an EA. Based on recent numbers, we 

now estimate a total of 22,860 hours for 

animal drugs (a decrease of 27,090 

hours). 

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 114 10 1,140 3 3,420 

25.40(a) and (c) ................................................................... 9 1 9 2,160 19,440 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,860 

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

VI. Estimated Annual Reporting Burden 

for Tobacco Products 

Under sections 905, 910, and 911 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 387e, 387j, and 387k), 

product applications and supplements, 

premarket tobacco applications 

(PMTAs), substantial equivalence (SE), 

exemption from SE, and modified risk 

tobacco product applications (MRTPAs) 

must contain a claim for categorical 

exclusion or an EA. The majority of the 

EA burden for tobacco products is 

covered under already existing 

information collections. The burden for 

SEs is currently approved under OMB 

control number 0910–0673; the burden 

for PMTAs are currently approved 

under OMB control number 0910–0768; 

the burden for SE exemptions are 

currently approved under OMB control 

number 0910–0684. 

FDA’s estimates are based on actual 

report data from fiscal year (FY) 2018 to 

FY 2020. On average, FDA estimated it 

received approximately 14 MRTPAs 

from 14 respondents. Based on updated 

data for this collection, FDA estimates 

14 EAs from 14 respondents. A total of 

14 respondents will submit an average 

of one application for environmental 

assessment. Based on FDA’s experience, 

previous information provided by 

potential sponsors, and knowledge that 

part of the EA information has already 

been produced in one of the tobacco 

product applications, FDA estimates 

that it takes approximately 80 hours to 

prepare an EA. Based on recent MRTPA 

numbers, we now estimate a total of 14 

annual responses and 1,120 hours for 

tobacco products (a decrease of 13 

responses and 1,040 hours). 

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.40(a) and (c) ................................................................... 14 1 14 80 1,120 

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

FDA estimates the burden for this 

information collection to be 30,315 

annual responses, and 314,736 hours. 

These estimates reflect an overall 

increase of 13,463 responses and 94,078 

hours. These adjustments are attributed 

to an increase in the number of 

responses the various centers in FDA 

have received over the last few years. 

Dated: August 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18239 Filed 8–24–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Common Technical 

Document; Data Standards; 

Specifications for the Electronic 

Common Technical Document 

Validation Criteria 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) and Center for Biologics 

Evaluation and Research (CBER) are 

announcing the date that FDA will 

begin rejecting submissions which fail 

Electronic Common Technical 

Document (eCTD) validations 1306 or 

1323 that have been raised to high 

validation errors as described in the 

‘‘Specifications for eCTD Validation 

Criteria.’’ 


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