Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4099 

Survey of Drug Product Manufacturing, 

Processing, and Packing Facilities—21 

CFR parts 210 and 211 

OMB Control Number 0910–NEW 

FDA has the responsibility to regulate 

the safety, as well as the efficacy and 

quality, of drugs in the United States. 

Under the Food and Drug 

Administration Safety and Innovation 

Act, enacted in 2012, the term current 

good manufacturing practice (CGMP) 

includes the implementation of 

oversight and controls over the 

manufacturing, processing, and packing 

of drugs to ensure quality, including 

managing the risk of, and establishing 

the safety of, raw materials used in the 

manufacture of drugs. The safety and 

availability of drugs can be affected by 

raw material suppliers, the material 

supply chain, and the facility’s controls 

over raw material quality. Risk 

management enables manufacturers to 

make proper choices and ensure the 

continued suitability of these materials 

and supply chains. The Agency needs to 

better understand how manufacturers, 

processors, and packers of drug 

products approach managing risks 

related to components, containers, and 

closures as well as the supply and 

distribution chains between the 

producers of raw materials and drug 

product manufacturers, processors, and 

packers. Such information will allow 

FDA to examine the potential economic 

impact of changes to regulations that 

govern the manufacturing, processing, 

and packing of drugs. 

In the Federal Register of September 

18, 2020 (85 FR 58370), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. Although one comment 

was received, it was not responsive to 

the four collection of information topics 

solicited and therefore will not be 

discussed in this document. 

This is a one-time information 

collection, the primary purpose of 

which is to collect industry-wide data 

on how facilities that manufacture, 

process, and pack drug products for use 

in humans and/or animals ensure the 

quality of their operations, including 

their current risk management 

approaches and practices for ensuring 

the quality and suitability of the drug 

components, containers, and closures 

that they use. FDA intends to use this 

information to inform its economic 

analyses of potential updates to CGMPs 

for human and animal drug product 

manufacturing, processing, and packing 

facilities under 21 CFR parts 210 and 

211. Survey respondents will be 

contacted by email or, if necessary, by 

regular mail. Respondents will be able 

to take the survey online or, if 

requested, they can return a hard copy 

by mail. FDA estimates the maximum 

burden of this collection of information 

as follows: 

TABLE 1.—ESTIMATED BURDEN HOURS FOR ONE-TIME DATA COLLECTION1

Type of respondent/facility Number of respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

Group 1: Facilities in United States engaged in drug manufacturing (in addition to other possible activities).394 1 394 1.1 ............... 433 

Group 2: Facilities in United States not engaged in manufacturing but engaged in other forms of drug processing 

or packing (e.g., labeling, repacking, etc.).

333 1 333 0.75 .............

(45 minutes) 

250 

Group 3: Facilities outside United States engaged in drug 

manufacturing (in addition to other possible activities).

407 1 407 2.20 ............. 895 

Group 4: Facilities outside United States not engaged in 

manufacturing but engaged in other forms of drug processing or packing (e.g., labeling, repacking, etc.).

261 1 261 1.5 ............... 392 

Total ........................................................................................ 1,395 ........................ 1,395 ..................... 1,970 

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

Burden hours are based on pretests of 

the survey and interviews with industry 

representatives and reflect the time 

required by each type of respondent to 

read the survey invitation and 

instructions and complete the survey 

questions. The total estimated one-time 

burden hours are 1,970. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00838 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Faculty Loan 

Repayment Program; OMB No. 0915– 

0150—Revision 

AGENCY: Health Resources and Services 

Administration, (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 16, 

2021. 

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 Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

4100 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Faculty Loan Repayment Program 

OMB No.: 0915–0150—Revision. 

Abstract: HRSA’s Bureau of Health 

Workforce administers the Faculty Loan 

Repayment Program (FLRP). FLRP 

provides degree-trained health 

professionals from disadvantaged 

backgrounds based on environmental 

and/or economic factors the opportunity 

to enter into a contract with the HHS in 

exchange for the repayment of 

qualifying educational loans for a 

minimum of 2 years of service as a fulltime or part-time faculty member at 

eligible health professions schools. 

A 60-day notice published in the 

Federal Register on October 6, 2020, 

vol. 85, No. 194; pp. 63120–21. There 

were no public comments. 

Need and Proposed Use of the 

Information: The information collected 

will be used to evaluate applicants’ 

eligibility to participate in FLRP and to 

monitor FLRP related activities. The 

FLRP intends to include a 

Disadvantaged Background (DB) form in 

the FLRP application. FLRP applicants 

are required to provide certification 

from a health professions school 

previously attended that identifies the 

individual as coming from an 

economically or environmentally 

disadvantaged background. In the past, 

applicants provided this information in 

varying formats. The DB form is not 

requesting new information from FLRP 

applicants. The form will allow an 

easier method for applicants to compete 

and convey their DB status and will 

standardize the collection of 

information. The information collected 

will be used to evaluate applicants’ rank 

and tier in the FLRP award process. 

Likely Respondents: FLRP applicants 

and institutions providing employment 

to the applicants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

Total Estimated Annualized burden 

hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Eligible Applications ............................................................. 186 1 186 1 186 

Institution/Loan Repayment Employment Form .................. *186 1 186 1 186 

Authorization to Release Information Form ......................... 186 1 186 .25 46.5 

Disadvantaged Background Form ....................................... 186 1 186 .20 37.2 

Total ..................................................................................... 744 ........................ 744 ........................ 455.70 

*Respondent for this form is the institution for the applicant. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–00808 Filed 1–14–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0263] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before March 16, 2021. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0263– 

60D, and project title for reference, to 

Sherrette Funn, the Reports Clearance 

Officer, Sherrette.funn@hhs.gov, or call 

202–795–7714. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Incident Report 

Form—the Protection of Human 

Subjects: Assurance Identification/IRB 

Certification/Declaration of Exemption 

Form. 

Type of Collection: OMB No. 0990– 

0263 Office of the Assistant Secretary 

for Health, Office for Human Research 

Protections. 

Abstract: The Office of the Assistant 

Secretary for Health, Office for Human 

Research Protections is requesting is 

requesting a three-year extension of the 

Protection of Human Subjects: 

Assurance Identification/IRB 

Certification/Declaration of Exemption 

Form, OMB No. 0990–0263. 

This form will facilitate prompt 

reporting of specific human subject