Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40853 

Antibody Cocktails for the Passive 

Immunization Component of PostExposure Prophylaxis.’’ 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 associated with 

submissions of content and format of 

labeling for drugs and biologics in 21 

CFR 201.56 and 201.57 have been 

approved under OMB control number 

0910–0572; the collections of 

information associated with 

submissions of investigational new drug 

applications in 21 CFR part 312 have 

been approved under OMB control 

numbers 0910–0014; the collections of 

information associated with 

submissions of applications for approval 

to market a new drug in 21 CFR part 314 

have been approved under 0910–0001; 

the collections of information associated 

with the reporting and recordkeeping of 

postmarketing adverse drug experiences 

have been approved under OMB control 

numbers 0910–0001, 0910–0230, 0910– 

0291, and 0910–0645; and the 

collections of information associated 

with general licensing provisions for 

biologics in 21 CFR part 601 have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16175 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0584] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Pilot Survey To 

Develop Standardized Reporting 

Forms for Federally Funded Public 

Health Projects 

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 information 

collection associated with a pilot survey 

to develop standardized reporting forms 

for capturing performance data for 

federally funded public health projects. 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 27, 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 September 27, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 27, 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– 

2021–N–0584 for ‘‘Pilot Survey to 

Develop Standardized Reporting Forms 

for Federally Funded Public Health 

Projects administered by the Office of 

Regulatory Affairs (ORA).’’ 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 


jbell on DSKJLSW7X2PROD with NOTICES
40854 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, 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 

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. 

Pilot Survey To Develop Standardized 

Reporting Forms for Federally Funded 

Public Health Projects 

OMB Control Number 0910–NEW 

This information collection supports 

federally funded public health projects 

administered by the Agency’s Office of 

Regulatory Affairs (ORA). As part of 

FDA’s efforts to protect the public 

health, we work collaboratively with 

State partners to enhance oversight of 

FDA-regulated products. Consistent 

with applicable regulations pertaining 

to federally funded programs, we 

currently collect information related to 

an awardee’s progress in completing 

agreed-upon performance metrics 3 to 4 

times a year during the performance 

period. Respondents to the information 

collection are recipients of FDA-funded 

projects who submit required 

information to FDA in free text and 

narrative form via portable document 

format (pdf). To increase our efficiency 

in evaluating program effectiveness and 

return-on-investment (ROI)/return-onvalue (ROV) for the federally funded 

projects that we administer, we intend 

to develop and establish the use of 

digital forms that contain standardized 

questions to capture data elements 

necessary to measure/track ROI/ROV. 

We believe the use of standardized 

forms will reduce the time required by 

awardees in completing and submitting 

progress reports. 

As part of the pilot, respondents will 

complete an initial report and progress/ 

performance reports, which include 

data fields to identify the award project 

and contact person and directs specific 

questions to respondents regarding 

project and progress updates. Based on 

public feedback, we hope to revise the 

reports, tailoring for project specificity 

and purpose, to include, but not limited 

to, improvements, such as drop-down 

menu selections and potential common 

response indicators that will reduce 

time for respondents and allow us to 

more quickly process information and 

determine impacts at the Agency level. 

As information will be requested of 

actively funded projects, it may become 

necessary to request additional 

information for a particular project to 

complete the performance evaluation(s) 

in a timely manner. To ensure data is 

sufficient, on a case-by-case basis, FDA 

anticipates a need for followup 

questionnaire(s) to supplement the 

progress reports as instruments of 

collection are developed and fine-tuned 

through this effort. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Awardee activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Initial Report ......................................................................... 400 1 400 10 4,000 

Progress Reports ................................................................. 400 2 800 40 32,000 

Supplement or Followup Report (if applicable) ................... 100 1 100 10 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 37,000 

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

We estimate that 400 respondents will 

participate under this pilot project and 

will submit an average of 3 to 4 reports 

within a single budget year (table 1). To 

ensure adequate reporting will be 

achieved over the course of this pilot, 

the option for a supplement or followup 

report is included in the estimated 

reporting burden; however, the need for 

these reports will be determined on a 

case-by-case basis with the FDA project 

manager. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40855 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Awardee activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

Records related to Initial Report ....... 400 1 400 0.5 hour (30 minutes) ....................... 200 

Records related to Progress Reports 400 2 800 0.5 hour (30 minutes) ....................... 400 

Records related to Supplement or 

Followup Report (if applicable).

100 1 100 0.5 hour (30 minutes) ....................... 50 

Total ........................................... ........................ ........................ ........................ ........................................................... 650 

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

Recordkeeping activities include 

storing and maintaining records related 

to submitting a request to participate in 

the project and compiling reports. 

Respondents should use current record 

retention capabilities for electronic or 

paper storage to achieve these activities. 

We assume it will take 0.5 hour/year to 

ensure the documents related to 

submitting a request to participate in the 

program are retained properly according 

to their existing recordkeeping policies, 

but no less than 3 years, as 

recommended by FDA (table 2). 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Awardee activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Coordination with partnering entities related to Initial Report ................................................................................... 300 2 600 8 4,800 

Coordination with partnering entities related to Progress 

Reports ............................................................................. 300 4 1,200 8 9,600 

Coordination with partnering entities related to Supplement 

or Followup Report (if applicable) .................................... 100 2 200 8 1,600 

Total .............................................................................. ........................ ........................ ........................ ........................ 16,000 

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

For those pilot projects that involve a 

participant composed of partnering 

entities in the program, FDA is taking 

into consideration the time that 

partnering entities will spend 

coordinating with each other in a pilot 

project. We estimate that 300 

respondents will work with their 

respective partnering entities and the 

average number of partnering entities 

will be 2. We assume each respondent 

will spend 8 hours coordinating with 

each partnering entity on each response 

for this pilot. We estimate that seven 

respondents will need to coordinate 

with an average of two partnering 

entities to create progress reports and 

the final report to submit to FDA (table 

3). 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16192 Filed 7–28–21; 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 Study Data Submission; 

Data Standards; Technical Rejection 

Criteria for Study Data Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing the effective date for 

Electronic Common Technical 

Document (eCTD) validations 

referenced in FDA’s ‘‘Technical 

Rejection Criteria for Study Data’’ (TRC). 

DATES: The eCTD validations will 

become applicable on September 15, 

2021. 

ADDRESSES: You may submit either 

electronic or written comments 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’’). 


jbell on DSKJLSW7X2PROD with NOTICES