20420 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, is the subject 

of NDA 019527, held by Bausch Health 

US, LLC, and initially approved on 

February 2, 1987. PEPCID is indicated 

in adults for the treatment of active 

duodenal ulcer (DU); active gastric 

ulcer; symptomatic nonerosive 

gastroesophageal reflux disease (GERD); 

erosive esophagitis due to GERD, 

diagnosed by biopsy; treatment of 

pathological hypersecretory conditions 

(e.g., Zollinger-Ellison syndrome, 

multiple endocrine neoplasias); and 

reduction of the risk of DU recurrence. 

PEPCID is indicated in pediatric 

patients 1 year of age and older for the 

treatment of peptic ulcer, and GERD 

with or without esophagitis and 

ulcerations. PEPCID is indicated in 

pediatric patients from birth to less than 

1 year of age for the treatment of GERD. 

In a letter received on January 11, 

2019, the applicant notified FDA that 

PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Ajanta Pharma USA Inc., submitted a 

citizen petition dated October 11, 2021 

(Docket No. FDA–2021–P–1097), and 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated 

October 13, 2021 (Docket No. FDA– 

2021–P–1111), both under 21 CFR 

10.30, requesting that the Agency 

determine whether PEPCID (famotidine) 

for oral suspension, 40 mg/5 mL, was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petitions 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioners have 

identified no data or other information 

suggesting that PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of PEPCID 

(famotidine) for oral suspension, 40 mg/ 

5 mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PEPCID (famotidine) for 

oral suspension, 40 mg/5 mL, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to PEPCID (famotidine) for oral 

suspension, 40 mg/5 mL, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: March 31, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07391 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0242] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Current Good 

Manufacturing Practices for Positron 

Emission Tomography Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 collection of 

information under FDA’s current good 

manufacturing practice (CGMP) 

regulations for positron emission 

tomography (PET) drugs. PET is a 

medical imaging modality involving the 

use of a unique type of 

radiopharmaceutical drug product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 6, 2022. 

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 June 6, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 6, 2022. 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 


khammond on DSKJM1Z7X2PROD with NOTICES
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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 Docket No. FDA–2013–N– 

0242 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Current 

Good Manufacturing Practices for 

Positron Emission Tomography Drugs.’’ 

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. Eastern Time, 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: 

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. 

Current Good Manufacturing Practices 

for Positron Emission Tomography 

Drugs—21 CFR Part 212 

OMB Control Number 0910–0667— 

Revision 

FDA CGMP regulations in part 212 

(21 CFR part 212) are intended to ensure 

that PET drug products meet the 

requirements of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) regarding 

safety, identity, strength, quality, and 

purity and are issued under the 

provisions of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115). These 

CGMP requirements are designed 

according to the unique characteristics 

of PET drugs, including their short halflives and because most PET drugs are 

produced at locations close to the 

patients to whom the drugs are 

administered. 

I. Investigational and Research PET 

Drugs 

Section 212.5(b) (21 CFR 212.5(b)) 

provides that for investigational PET 

drugs produced under an investigational 

new drug application (IND) and 

research PET drugs produced with 

approval of a Radioactive Drug Research 

Committee (RDRC), PET producers must 

meet the requirement (FD&C Act) to 

follow CGMP by complying with the 

regulations under part 212 or complying 

with United States Pharmacopeia (USP) 

32 Chapter 823. We believe that PET 

production facilities producing drugs 

under INDs and RDRCs are already 

substantially complying with the 

recordkeeping requirements of USP 32 

Chapter 823 (see section 121(b) of 

FDAMA). Some IND and RDRC PET 

facilities also produce PET drugs 

approved under abbreviated new drug 

applications (ANDAs) or new drug 

applications (NDAs), and our estimates 

include these facilities. The facilities 

described above are included under 

academia or small firms. The corporate 

sites that also produce IND PET drugs 

are included in the estimated 91 

individual corporate sites. 

To estimate the amount of time that 

respondents have spent complying with 


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CGMP requirements, we relied on the 

following: 

• Informal communications with PET 

producers. 

• FDA staff visits to PET production 

facilities. 

• Our experience with PET drug 

applications, including amendment and 

supplement submissions. 

• Our general knowledge of 

pharmaceutical manufacturing 

practices. 

• Various CGMP compliance reports 

FDA received from 2019 to 2021. 

II. Recordkeeping Burden 

A. One-Time Recordkeeping Burden for 

Corporate Firms 

We estimate that corporate firms will 

have to employ one-time and annual 

recordkeeping. We estimate that, for 

some major PET manufacturing 

corporations, most of the quality, 

manufacturing, and testing procedures 

are developed at the corporate level and 

issued to the individual production and 

testing sites located in various States 

across the country. It is estimated that 

a total of 91 of these individual 

corporate sites are controlled among 4 

major corporations. Thus, we have 

calculated the burden for 4 

recordkeeping activities as a one-time 

effort for creating standard operating 

procedures (SOPs) and master batch 

records (MBRs) instead of 91 

recordkeeping activities for individual 

corporate sites. 

Each corporate firm is estimated to 

expend approximately 8 hours to create 

1 MBR per PET drug. We estimate that 

4 corporate firms will each create and 

maintain 10 MBRs associated with 

production and quality control (QC) 

testing procedures (a total of 40 

records), which results in a total 

recordkeeping burden of approximately 

320 hours. 

Sections 212.20(c), 212.30(b), 

212.50(d), and 212.60(f) (21 CFR 

212.20(c), 212.30(b), 212.50(d), and 

212.60(f) contain written SOP 

provisions for equipment operation, 

maintenance, and cleaning, including 

maintenance of physical facilities. We 

estimate that 4 corporate firms will 

expend approximately 5 hours each to 

establish and maintain 13 procedures 

for equipment and facility maintenance 

(a total of 52 procedures), which results 

in a total recordkeeping burden of 

approximately 260 hours. 

Sections 212.20(b) and 212.40(a) and 

(b) contain requirements on SOPs 

regarding receiving, testing, and 

accepting components. We estimate that 

4 corporate firms will expend 

approximately 8 hours each to create 1 

procedure for acceptance of raw 

materials and components (a total of 4 

procedures), which results in a total 

recordkeeping burden of approximately 

32 hours. 

We estimate that approximately 4 

corporate firms will expend 2 hours 

each to create 25 specification data 

sheets for components (a total of 100 

specification data sheets), which results 

in a total recordkeeping burden of 

approximately 200 hours. 

Section 212.71(a) and (b) requires that 

PET drug firms establish procedures for 

rejecting PET drug batches that do not 

conform to established specifications 

and requires that PET drug firms 

establish procedures for investigating 

deviations and out-of-specifications 

(OOS) failures of products during 

manufacturing and testing. Section 

212.50(a) also requires that firms 

establish written production and 

process control procedures to ensure 

and document that all key process 

parameters are controlled and that any 

deviations from the procedures are 

justified. We estimate that 4 corporate 

firms will expend approximately 8 

hours each to establish 1 procedure (a 

total of 4 procedures), which results in 

a total recordkeeping burden of 

approximately 32 hours. 

Section 212.90(a) requires the 

establishment and maintenance of 

written procedures for the distribution 

of PET drug products. We estimate that 

4 corporate firms will each expend 

approximately 8 hours to establish and 

maintain 1 written procedure regarding 

the distribution of PET drugs (a total of 

4 records), which results in a total 

recordkeeping burden of approximately 

32 hours. 

Sections 212.20(e) and 212.100(a), (b), 

and (c) require that PET drug firms 

establish and maintain written 

procedures for handling complaints and 

establish and maintain procedures for 

field alert reports (FARs). We estimate 

that 4 corporate firms will each 

establish 3 written procedures (a total of 

12 procedures) and that each corporate 

firm will expend approximately 8 hours 

for each procedure. Establishing and 

maintaining written procedures results 

in a total recordkeeping burden of 

approximately 96 hours. 

B. One-Time Recordkeeping Burden for 

Academia, Small Firms, and High-Risk 

Component Manufacturers 

A total of 63 combined sites represent 

academia and small commercial firms, 

including some IND and RDRC sites 

manufacturing ANDA-approved and 

NDA-approved PET drugs, and high-risk 

component manufacturers. Of the 63 

combined sites (herein and the other 

sections of this document referred to as 

‘‘entities’’), 14 producers of starting 

materials, precursors, generators, and 

sterile component material 

manufacturing for kits are also required 

to comply with selected regulations in 

part 212, according to the PET drug 

definition in section 121(a) of FDAMA 

and codified in section 201(ii)(1)(A) of 

the FD&C Act (21 U.S.C. 321(ii)(1)(A)). 

We refer to such producers as high-risk 

component manufacturers in tables 2 

and 5. 

The 63 entities will expend 

approximately 8 hours each to create 

MBRs and manufacturing and quality 

procedures. We estimate that the 

entities will each maintain 8 records (a 

total of approximately 504 records), 

which results in a total recordkeeping 

burden of 4,032 hours. 

Each of the entities will expend 

approximately 8 hours to create 

equipment-related and facility-related 

procedures (consistent with corporate 

firms discussed in section II.A above). A 

total of 63 entities will each maintain an 

estimated 12 records (a total of 756 

records), which results in a total 

recordkeeping burden of approximately 

6,048 hours. 

The estimated burden for the 63 

entities to each create and maintain 12 

procedures for acceptance of raw 

materials and components (a total of 126 

procedures) is approximately 8 hours 

per procedure. The creation and 

maintenance of these procedures results 

in a total recordkeeping burden of 

approximately 1,008 hours. 

We estimate that the 63 entities will 

each expend approximately 30 minutes 

to create and maintain 21 specification 

data sheets (a total of 1,323). The 

creation and maintenance of 

specification data sheets results in a 

total recordkeeping burden of 

approximately 662 hours. 

We estimate that approximately 63 

entities will each create 1 procedure 

relating to deviations and OOS 

investigations and 1 procedure relating 

to the distribution of finished products 

(2 procedures for a total of 126). Each 

of these entities will expend 8 hours per 

procedure, which results in a total 

recordkeeping burden of 1,008 hours— 

504 hours for each procedure. 

We estimate that each of the 63 

entities will create approximately 3 

procedures relating to customer 

complaints, returned products, and FAR 

(a total of 189 records). Each of these 

entities will expend 8 hours per record, 

which results in a total recordkeeping 

burden of 1,512 hours. 


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C. Annual Recordkeeping Burden for 

Corporate Firms 

As discussed in section II.A, we 

estimate that there are a total of 91 

individual corporate sites controlled 

under 4 major corporations. The 

information collection discussed in this 

section relates to individual PET drugs 

manufactured at each of the sites 

located across the country. 

We estimate that the 91 corporate 

sites will each expend approximately 30 

minutes to fill 240 batches 

(approximately 20 batches each month 

and a total of 21,840 batches for all 91 

sites), which results in a total 

recordkeeping burden of 10,920 hours. 

We further estimate that, annually, 

corporate firms may have to create some 

new batch records or quality records for 

newly introduced or existing drugs. 

We estimate that the 4 major 

corporations will each expend 

approximately 8 hours to create 9 new 

quality procedure and MBRs (a total of 

36 records), which results in a total 

recordkeeping burden of 288 hours. 

We estimate that approximately 91 

individual corporate sites will each 

expend approximately 15 minutes to 

create 480 records for equipment 

maintenance, cleaning, calibration, and 

facilities maintenance (a total of 43,680 

records), which results in a total 

recordkeeping burden of 10,920 hours. 

Sections 212.20(b) and (c) and 

212.40(a) and (b) set forth requirements 

for acceptance of raw materials and 

component shipments received at the 

centrally controlled, corporate quality 

assurance (QA) facilities annually. We 

estimate that the 4 corporate QA sites, 

internally located within corporate 

administrative sites, will create 48 

records for incoming raw material 

acceptance (a total of 192 records) for 

approximately 4 bulk shipments per 

month (12 × 4) on behalf of the 

individual corporate sites. Corporate QA 

sites will expend approximately 2 hours 

to create records, which results in a total 

recordkeeping burden of 384 hours. 

Sections 212.60(g), 212.61(b), and 

212.70(d)(2) and (d)(3) set forth 

requirements for documenting 

laboratory testing results obtained from 

each PET drug manufactured and 

referred to in laboratory testing, 

including final release testing. Each of 

the 91 individual corporate firms must 

maintain records of different tests for 

each of their products. We estimate that 

approximately 91 individual corporate 

sites will each expend 30 minutes to 

document 240 records of cumulative QC 

test results (1 record that includes 5 to 

6 tests and a total of 21,840 records), 

which results in a total recordkeeping 

burden of approximately 10,920 hours. 

We estimate approximately 2 hours 

for each of the 91 individual corporate 

sites to record OOS events and perform 

investigations for each incident. We also 

estimate that the individual corporate 

sites will each conduct an average of 2 

OOS investigations per site (a total of 

182 records for OOS investigations), 

which results in a total recordkeeping 

burden of 364 hours. This estimate 

includes reprocessing or conditional 

release events, which are very rare. 

Section 212.100(b) and (c) requires 

that PET drug firms document how they 

handle each complaint that they receive. 

We estimate that each of the 4 corporate 

QA sites will expend approximately 2 

hours to document and investigate 1 

complaint. Because complaints are 

usually investigated at the corporate 

firm level, we estimate that each 

corporate QA site will receive and 

handle 5 complaints annually (a total of 

20 complaints for documentation), 

which results in a total recordkeeping 

burden of 40 hours. 

Our estimate for PET drug firmsperforming QA and release of 

manufactured PET drugs from the 91 

individual corporate sites is 

approximately 5,460 hours from 21,840 

released batches (15 minutes per batch 

for each of the 240 released batches). 

Section 212.90(b) requires that 

corporate firms maintain distribution 

records. We estimate that each of the 91 

corporate firms will expend 

approximately 5,460 hours to release 

21,840 batches (15 minutes per batch for 

each of the 240 released batches). 

D. Annual Recordkeeping Burden for 

Academia and Small Firms 

We assume that each academia and 

small firm will expend the same amount 

of time to perform the same information 

collection activities as corporate firms 

(discussed in section II.A above). 

Approximately 49 academia and 

small firms will each expend 

approximately 30 minutes to fill 96 

batch and production records (a total of 

4,704 records), which results in a total 

recordkeeping burden of 2,352 hours. 

For the 49 academia and small firms 

to create new MBRs or quality records, 

we estimate they will expend 8 hours 

per record (147 total records (3 per 

site)), which results in a total 

recordkeeping burden of 1,176 hours. 

We estimate that approximately 49 

academia and small firms will maintain 

23,520 calibration and cleaning records 

(480 records per site), such as logbooks 

for each piece of equipment and 

documentation of calibration records in 

each PET production firm. The 

calibration efforts for academia and 

small firms is twice per year per 

equipment (10 pieces of equipment per 

site). In addition, we estimate that 

academic and small firms will each 

expend 30 minutes to maintain records, 

which results in a total recordkeeping 

burden of 11,760 hours. 

Under §§ 212.20(b) and (c) and 

212.40(a) and (b), academia and firms 

will maintain a total of approximately 

588 raw material and component 

acceptance records (12 shipments per 

year). We estimate that they will expend 

30 minutes to create records, which 

results in a total recordkeeping burden 

of 294 hours. 

We estimate that approximately 49 

academia and small firms will each 

expend 30 minutes to document a total 

of 4,704 laboratory QC test records (96 

records per site), which results in a total 

recordkeeping burden of approximately 

2,352 hours. 

We estimate that approximately 49 

academic and small firms will each 

maintain records of OOS and customercomplaint events and perform 

investigations and that they will expend 

approximately 2 hours annually for 

these activities. We also estimate an 

average of 2 OOS events and 2 customer 

complaints and investigations per firm, 

with a total of 392 hours for each 

category (196 for each site). This 

estimate includes any reprocessing or 

special batch release events, which have 

been rarely observed. 

We estimate that approximately 49 

academia and small firms will each 

perform QA and release of 

manufactured PET drugs and that they 

will expend 15 minutes per batch (96 

batches per site), which results in a total 

recordkeeping burden of 1,176 hours for 

4,704 batches. 

Section 212.90(b) requires that 

academia and small firms maintain 

distribution records. We estimate that it 

will take approximately 15 minutes per 

batch (96 batches per site) to create a 

distribution record for each batch of 

PET drug product, with a total 

recordkeeping burden of approximately 

1,176 hours for 4,704 batches per site. 

E. Annual Recordkeeping Burden for 

High-Risk Component Manufacturers 

(Producers of Starting Materials, 

Precursors, Generators, and Sterile Raw 

Materials) 

According to section 121(a) of 

FDAMA, the PET drug definition 

includes any non-radioactive or 

radioactive reagents, kits, nuclidic 

generators, target materials, 

synthesizers, or other apparatus or 

computer program to be used in 

preparation of PET drug. FDA performs 


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risk assessments of each manufacturer 

and inspects such manufacturers. 

Producers of sterile kit components, 

precursors, and generators are included 

in this category, including producers of 

sterile raw materials. We have estimated 

that 14 such facilities be included in 

this category based on inspections and 

have included them in this section. 

These manufacturers must comply with 

selected sections of part 212 since they 

are not producing the final PET drug 

products to be administered to patients. 

As stated in section II.B, we refer to 

such producers as high-risk component 

manufacturers in tables 2 and 5. 

We estimate that approximately 14 

high-risk component manufacturers will 

expend 30 minutes to complete each 

manufacturing batch record (24 batches 

per site) and that there will be a total of 

336 records, which results in a total 

recordkeeping burden of approximately 

168 hours. 

We also estimate that the 14 high-risk 

component manufacturers will each 

expend approximately 30 minutes to 

create and file equipment calibration 

and cleaning and facility maintenancerelated records (130 records each and a 

total of 1,820), which results in a total 

recordkeeping burden of 910 hours. 

We estimate that the 14 such 

manufacturers will each expend 30 

minutes to document 24 records for 

components, containers, and closures 

for incoming acceptance tests (a total of 

336 batches), which results in a total 

recordkeeping burden of approximately 

168 hours from all sites. 

We estimate that the 14 such 

manufacturers will expend 30 minutes 

to document 24 laboratory testing 

records for 336 batches, which results in 

a total burden of approximately 168 

hours. These manufacturers will also 

document OOS investigations for any 

laboratory test failures (1 record for each 

site), which results in a total 

recordkeeping burden of 14 hours. 

We also estimate that such 

manufacturers will perform QA and 

release manufactured PET drugs for a 

total of 336 batches (24 each) released 

annually. In addition, we estimate that 

such manufacturers will expend 

approximately 15 minutes per batch, 

which results in a total recordkeeping 

burden of 84 hours. 

We estimate that such manufacturers 

will each expend approximately 15 

minutes to create and maintain 

distribution records that will result in 

336 records (24 each). The total 

recordkeeping burden hours will result 

in 84 hours. 

F. One-Time and Annual Recordkeeping 

for External Control Testing 

Laboratories 

We have included a new category of 

facilities—external control testing 

laboratories—in this information 

collection. These testing laboratories 

perform chemical, microbiological, or 

sterility testing functions to support 

manufacturing and release of final PET 

drug products. Assignment and 

inspection of control testing laboratories 

may be determined through risk-based 

assessments. We have estimated that 23 

such facilities be included in this 

category, based on inspections and NDA 

and ANDA applications that FDA has 

received. These testing laboratories 

must comply with selected sections of 

part 212 (and compliance with 21 CFR 

part 211 is acceptable) since they are not 

producing the final PET drugs to be 

administered to patients. In this section, 

we refer to these testing laboratories as 

external testing facilities in general; 

however, in table 6, we refer to them as 

external control testing laboratories. 

We estimate that approximately 23 

external testing facilities will each 

expend 9 hours to complete testing SOP 

and validation of test methods and 

assays (6 records each and a total of 

138), which results in a total 

recordkeeping burden of approximately 

1,242 hours. 

We estimate that 23 external testing 

facilities will expend approximately 30 

minutes each to perform incoming 

acceptance test for testing materials and 

to create test result records, which 

results in a total recordkeeping burden 

of 368 hours. For incoming acceptance 

tests, sites will expend 276 hours (24 

records for a total of 552), and for testing 

records, sites will expend 92 hours (8 

records for a total of 184). 

We estimate that 23 external testing 

facilities will each document 2,254 

equipment cleaning and calibration 

records, 184 QA release records, and 23 

OOS investigation records, which 

results in a total recordkeeping burden 

of approximately 564, 23, and 46 hours, 

respectively (see table 6). 

III. Process Verification 

Section 212.50(f)(2) requires the 

recordkeeping of any process 

verification activities and results. PET 

drug producers usually perform process 

verification as a one-time activity before 

a product is approved or if any major 

manufacturing process or equipment 

changes are made. We have estimated 

that PET drug producers will conduct 

process verification under one-time 

batch creation for existing products; 

annual new creation of MBRs; and 

manufacturing and quality procedures 

for ongoing activities, including media 

fills (see tables 1 and 2). 

IV. Conditional Final Releases 

Section 212.70(f) requires that PET 

drug producers document any 

conditional final releases of a product. 

We believe that conditional final 

releases will be uncommon, and we 

have included them in the burden 

estimates under annual OOS 

investigations and final QA release 

efforts for each manufactured batch in 

tables 3 and 4. 

V. Reprocessing Procedures 

Sections 212.20(c) and 212.71(d) 

require that PET drug producers 

establish and document procedures for 

reprocessing PET drugs. We have rarely 

received reprocessing options for 

application of such drugs and, if 

reprocessing occurs, we have included 

such rare events in the burden estimates 

under annual QA release efforts in 

tables 3 and 4. 

VI. Third-Party Disclosure Burden for 

Sterility Test Failure Notices 

Section 212.70(e) requires that PET 

drug producers notify all receiving 

facilities if a batch fails sterility tests. 

FDA receives FARs based on confirmed 

sterility failures of released PET drugs. 

Based on the last 3 years’ sterility failure 

reports, we estimate that all 140 sites 

(91 individual corporate sites and 49 

academia and small firms) will send 

notifications to the affected clinical or 

receiving facilities of approximately 7 

failures. Therefore, we estimate that 7 

PET drug producers will submit 2 

reports to FDA and send 1 notification 

(a total of 3 reports) to FDA and the 

affected clinical or receiving site per 

year. PET drug producers would submit 

the notice to the receiving site by email 

or Fax and submit the FAR notice to 

FDA electronically and would expend 

2.5 hours per incident, which results in 

a total burden of 53 hours. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20425 

TABLE 1—ESTIMATED ONE-TIME RECORDKEEPING BURDEN FOR CORPORATE FIRMS 1

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts C and F; §§ 212.20 to 212.50 

Master Batch Production and Quality Control Procedures 

(§§ 212.20(c) and (e) and 212.50(a) and (b)) .................. 4 10 40 8 320 

Subparts C, D, F, and G; §§ 212.20 to 212.60 

Equipment and Facilities Records (SOP) (§§ 212.20(c), 

212.30(b), 212.50(d), and 212.60(f)) ................................ 4 13 52 5 260 

Subparts C and E; §§ 212.20 to 212.40 

Records of Components, Containers, and Closures (SOP) 

(§§ 212.20(b) and 212.40(a) and (b)) ............................... 4 1 4 8 32 

Records of Components, Containers, and Closures (specification data sheets) (§§ 212.20(b) and (c) and 

212.40(a) and (b)) ............................................................ 4 25 100 2 200 

Subpart H; § 212.71 

.

OOS Investigations (SOP) (§ 212.71(a) and (b)) ................ 4 1 4 8 32 

Subpart J; § 212.90 

Distribution Records (SOP) (§ 212.90(a)) ............................ 4 1 4 8 32 

Subparts C and K; §§ 212.20 to 212.100 

Complaints and Returned Product (§§ 212.20(e) and 

212.100(a), (b), and (c)) ................................................... 4 3 12 8 96 

Total .............................................................................. ........................ ........................ 216 ........................ 972 

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

2Totals have been rounded to the nearest whole number. 

TABLE 2—ESTIMATED ONE-TIME RECORDKEEPING BURDEN FOR ACADEMIA, SMALL FIRMS, AND HIGH-RISK COMPONENT

MANUFACTURERS 1

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts C and F; §§ 212.20 to 212.50 

Batch Production and Control Records (§§ 212.20(c) and 

212.50(a) and (b)) ............................................................ 63 8 504 8 4,032 

Subparts C, D, F, and G; §§ 212.20 to 212.60 

Equipment and Facilities Records (SOP) (§§ 212.20(c), 

212.30(b), 212.50(d), and 212.60(f)) ................................ 63 12 756 8 6,048 

Subparts C and E; §§ 212.20 to 212.40 

Records of Components, Containers, and Closures (SOP) 

(§§ 212.20(b) and 212.40(a) and (b)) ............................... 63 2 126 8 1,008 

Records of Components, Containers, and Closures (specification data sheets) (§§ 212.20(b) and (c) and 

212.40(a) and (b)) ............................................................ 63 21 1,323 0.5 662 

Subparts C and H; §§ 212.20 to 212.71 

OOS Investigations (SOP) (§§ 212.20(c) and 212.71(a) 

and (b)) ............................................................................. 63 1 63 8 504 


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20426 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

TABLE 2—ESTIMATED ONE-TIME RECORDKEEPING BURDEN FOR ACADEMIA, SMALL FIRMS, AND HIGH-RISK COMPONENT

MANUFACTURERS 1—Continued 

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 2

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subpart J; § 212.90 

Distribution Records (SOP) (§ 212.90(a)) ............................ 63 1 63 8 504 

Subparts C and K; §§ 212.20 to 212.100 

Complaints and Returned Product (§§ 212.20(e) and 

212.100(a), (b), and (c)) ................................................... 63 3 189 8 1,512 

Total .............................................................................. ........................ ........................ 3,024 ........................ 14,270 

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

2Totals have been rounded to the nearest whole number. 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR CORPORATE FIRMS 1

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts C and F; §§ 212.20 to 212.50 

Batch Production Records (create batch-related records 

per year) (§§ 212.20(c) and (e) and 212.50(a) and (b)) .. 91 240 21,840 0.5 10,920 

Creating Any New Batch Records and Quality Records for 

New or Existing Drugs (§§ 212.20(c) and (e) and 

212.50(a) and (b)) ............................................................ 4 9 36 8 288 

Subparts D, F, and G; §§ 212.30 to 212.60 

Equipment and Facilities Records (calibration and cleaning 

records systems) (§§ 212.30(b), 212.50(d), and 

212.60(f)) .......................................................................... 91 480 43,680 0.25 10,920 

Subparts C and E; §§ 212.20 to 212.40 

Records of Components, Containers, and Closures for incoming inspection (§§ 212.20(b) and (c) and 212.40(a) 

and (b)) ............................................................................. 4 48 192 2 384 

Subparts G and H; §§ 212.60 to 212.70 

Laboratory Testing Records (record laboratory test results) 

§§ 212.60(g), 212.61(b), and 212.70(d)(2) and (d)(3) ...... 91 240 21,840 0.5 10,920 

Subpart H; § 212.71 

Out-of-Specification Investigations (record events and investigations) (§ 212.71(b)) ................................................ 91 2 182 2 364 

Subparts H and K; §§ 212.70 to 212.100 

Complaints (§ 212.100(b) and (c)) ....................................... 4 5 20 2 40 

QA and Release of Batches (§ 212.70) ............................... 91 240 21,840 0.25 5,460 

Subpart J; § 212.90 

Distribution Records (§ 212.90(b)) ....................................... 91 240 21,840 0.25 5,460 

Total .............................................................................. ........................ ........................ 131,470 ........................ 44,756 

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

2Totals have been rounded to the nearest whole number. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20427 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR ACADEMIA AND SMALL FIRMS 1

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts C and F; §§ 212.20 to 212.50 

Batch Production Records (filling batch-related records per 

year) (§§ 212.20(c) and (e) and 212.50(a) and (b)) ......... 49 96 4,704 0.5 2,352 

Creating Any New Batch Records and Procedures for 

New Drugs (§§ 212.20(c) and (e) and 212.50(a) and (b)) 49 3 147 8 1,176 

Subparts D, F, and G; §§ 212.30 to 212.60 

Equipment and Facilities Records (calibration and cleaning 

records) (§§ 212.30(b), 212.50(d), and 212.60(f)) ........... 49 480 23,520 0.5 11,760 

Subparts C and E; §§ 212.20 to 212.40 

Records of Components, Containers, and Closures (incoming acceptance tests) (§§ 212.20(b) and (c) and 

212.40(a) and (b)) ............................................................ 49 12 588 0.5 294 

Subparts G and H; §§ 212.60 to 212.70 

Laboratory Testing Records (QC test results) §§ 212.60(g), 

212.61(b), and 212.70(d)(2) and (d)(3) ............................ 49 96 4,704 0.5 2,352 

Subpart H; § 212.71 

Out-of-Specification Investigations (record events and investigations) (§ 212.71(b)) ................................................ 49 2 98 2 196 

Subparts H and K; §§ 212.70 to 212.100 

Complaints (Record events and investigations) 

(§ 212.100(b) and (c)) ....................................................... 49 2 98 2 196 

QA and Release of Batches (§ 212.70) ............................... 49 96 4,704 0.25 1,176 

Subpart J; § 212.90 

Distribution Records (§ 212.90(b)) ....................................... 49 96 4,704 0.25 1,176 

Total .............................................................................. ........................ ........................ 43,267 ........................ 20,678 

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

2 Totals have been rounded to the nearest whole number. 

TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HIGH-RISK COMPONENT MANUFACTURERS 1

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts C and F; §§ 212.20 to 212.50 

Batch Production (creating manufacturing records and 

batch-related records per year) (§§ 212.20(c) and (e) 

and 212.50(a) and (b)) ..................................................... 14 24 336 0.5 168 

Subparts D, F, and G; §§ 212.30 to 212.60 and 212.90 

Equipment and Facilities Records (calibration and cleaning 

records systems) (§§ 212.30(b), 212.50(d), and 

212.60(f)) .......................................................................... 14 130 1,820 0.5 910 

Subparts C and E; §§ 212.20 to 212.40 

Records of Components, Containers, and Closures (incoming acceptance test) (§§ 212.20(c) and 212.40(a) 

and (b)) ............................................................................. 14 24 336 0.5 168 


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20428 Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 

TABLE 5—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HIGH-RISK COMPONENT MANUFACTURERS 1—Continued 

Information collection activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

Subparts G and H; §§ 212.60 to 212.70 

Laboratory Testing Records (record QC test results) 

§§ 212.60(g), 212.61(b), and 212.70(d)(2) and (d)(3) ...... 14 24 336 0.5 168 

Subpart H; § 212.71 

OOS Investigations (record events and investigations) 

(§ 212.71(b)) ..................................................................... 14 1 14 1 14 

QA and Release of Batches (§ 212.70) ............................... 14 24 336 0.25 84 

Subpart J; §§ 212.90 to 212.50 

Distribution Records (§ 212.90(b)) ....................................... 14 24 336 0.25 84 

Total .............................................................................. ........................ ........................ 3,514 ........................ 1,596 

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

2Totals have been rounded to the nearest whole number. 

TABLE 6—ESTIMATED ONE-TIME AND ANNUAL RECORDKEEPING BURDEN FOR EXTERNAL CONTROL TESTING

LABORATORIES 1

Information collection activity; 21 CFR citation Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeper 

(in hours) 

Total hours 2

One-Time Recordkeeping Assay Validation (creating SOP 

and performing validation) ................................................ 23 6 138 9 1,242 

Subparts C, E, and F; §§ 212.20, 212.40, and 212.50 

Annual Recordkeeping Incoming Acceptance Tests 

Records (§§ 212.20(c), 212.40(a) and (b)) ...................... 23 24 552 0.5 276 

Annual Recordkeeping Batch Testing (creating testing 

records for sterility, periodic quality indicator test, or any 

test) (§§ 212.20(c) and (e) and 212.50(a) and (b)) .......... 23 8 184 0.5 92 

Subparts D, F, and G; §§ 212.30, 212.50, and 212.60 

Annual Recordkeeping Equipment and Facilities Records 

(calibration, cleaning, and maintenance records) 

(§§ 212.30(b), 212.50(d), and 212.60(f)) .......................... 23 98 2,254 0.25 564 

Subpart H; § 212.71 

Annual OOS Investigations (recording events and investigations) (§ 212.71(b)) ..................................................... 23 1 23 1 23 

Annual QA and Release of Test Results ............................ 23 8 184 0.25 46 

Total .............................................................................. ........................ ........................ 3,335 ........................ 2,243 

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

2Totals have been rounded to the nearest whole number. 

TABLE 7—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR PET DRUG PRODUCERS 1

Information collection activity; 21 CFR section 

Number of 

sterility 

failure 

incidents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

(in hours) 

Total hours 2

Subpart H; § 212.70 

Sterility Test Failure Notices 3 (§ 212.70(e)) ........................ 7 3 21 2.5 53 

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

2Totals have been rounded to the nearest whole number. 

3Two reports are sent to FDA per incident, and 1 notification is sent to the receiving site. 


khammond on DSKJM1Z7X2PROD with NOTICES

I I I 
Federal Register / Vol. 87, No. 67 / Thursday, April 7, 2022 / Notices 20429 

Our estimated burden for the 

information collection reflects an 

overall increase of 25,425 hours and a 

corresponding increase of 84,703 

records. We attribute this increase to the 

inclusion of external control testing 

laboratories that perform only 

specialized chemical, microbiological, 

or sterility testing functions to support 

manufacturing and release of final PET 

drug products. 

Dated: March 30, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07392 Filed 4–6–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4951] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA 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 information 

collection requirements for 

humanitarian use devices (HUDs). 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 6, 2022. 

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 June 6, 2022. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of June 6, 2022. 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– 

2017–N–4951 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Medical 

Devices; Humanitarian Use Devices.’’ 

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: 

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 


khammond on DSKJM1Z7X2PROD with NOTICES