77528 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in the following table have 

been approved by OMB: 

21 CFR part; guidance; or FDA form Topic OMB 

Control No. 

‘‘The Accreditation Scheme for Conformity Assessment 

(ASCA) Program’’.

ASCA Program ..................................................................................... 0910–0889 

807, subpart E .................................................................... Premarket notification ........................................................................... 0910–0120 

814, subparts A through E ................................................. Premarket approval .............................................................................. 0910–0231 

814, subpart H .................................................................... Humanitarian Device Exemption .......................................................... 0910–0332 

812 ...................................................................................... Investigational Device Exemption ........................................................ 0910–0078 

860, subpart D .................................................................... De Novo classification process ............................................................ 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions ...................................................................................... 0910–0756 

803 ...................................................................................... Medical Devices; Medical Device Reporting; Manufacturer reporting, 

importer reporting, user facility reporting, distributor reporting.

0910–0437 

820 ...................................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) 

Regulation.

0910–0073 

58 ........................................................................................ Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.0910–0119 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21673 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2583] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Human Drug 

Compounding, Repackaging, and 

Related Activities Regarding Sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 23, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0858. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Human Drug Compounding, 

Repackaging, and Related Activities 

Regarding Sections 503A and 503B of 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910–0858— 

Extension 

This information collection helps 

support implementation of sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 353a and 21 U.S.C. 353b), which 

govern compounding by pharmacies, 

outsourcing facilities, and other entities. 

Compounding is generally a practice in 

which a licensed pharmacist, a licensed 

physician, or, in the case of an 

outsourcing facility, a person under the 

supervision of a licensed pharmacist, 

combines, mixes, or alters ingredients of 

a drug to create a medication tailored to 

the needs of an individual patient. 

Although compounded drugs can serve 

an important medical need for certain 

patients, they also present risks to 

patients. FDA’s compounding program 

aims to protect patients from unsafe, 

ineffective, and poor-quality 

compounded drugs, while preserving 

access to lawfully marketed 

compounded drugs for patients who 

have a medical need for them. 

Respondents to the information 

collection are pharmacies, outsourcing 

facilities, and other entities. 

To assist respondents in complying 

with statutory requirements, we have 

issued the following topic-specific 

guidance documents: 

TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT

Title Notice of availability publication date 

Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities (Radiopharmaceutical Compounding and Repackaging 

Guidance) (available at https://www.fda.gov/media/102615/download).

September 26, 2018 (83 FR 48633). 


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1 Guidance documents applicable to animal drug 

compounding regulated by the Center for Veterinary 

Medicine would also be returned if no FDA 

Organization is selected; this information collection 

covers only those compounding guidance 

documents issued by the Center for Drug Evaluation 

and Research and Center for Biologics Evaluation 

and Research. 

TABLE 1—PUBLISHED GUIDANCE DOCUMENTS REGARDING SECTIONS 503A AND 503B OF THE FD&C ACT—Continued 

Title Notice of availability publication date 

Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance) (available at https://

www.fda.gov/media/102637/download).

September 26, 2018 (83 FR 48630). 

Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (Repackaging 

Guidance) (available at https://www.fda.gov/media/90978/download).

January 13, 2017 (82 FR 4343). 

Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Biological Products Guidance) (available at https://www.fda.gov/media/90986/ 

download).

January 19, 2018 (83 FR 2787). 

The guidance documents also 

describe conditions under which FDA 

generally does not intend to take 

enforcement action for violations of the 

FD&C Act. These guidance documents 

were issued consistent with FDA’s good 

guidance practice regulations in 21 CFR 

10.115, which provide for public 

comment at any time. The guidance 

documents communicate FDA’s current 

thinking on the respective topics and 

include information collection that may 

result in expenditures of time and effort 

by respondents. In FDA’s notices of 

availability for the guidance documents, 

we also solicited public comment under 

the PRA on the information collection 

provisions. FDA has developed and 

maintains a searchable guidance 

database available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Guidance documents covered by this 

information collection may be found by 

choosing ‘‘Center for Drug Evaluation 

and Research’’ from among the FDA 

Organizations, and by selecting the term 

‘‘Compounding’’ from among the 

possible filters.1

In the Federal Register of June 12, 

2024 (89 FR 49880), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

information collection as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Recommended activity; guidance section Number of 

respondents 

Number of 

disclosures 

per respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance 

Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (section III.B of the Radiopharmaceutical 

Compounding and Repackaging Guidance by Outsourcing Facilities). 2 2 4 3 12 

Repackaging Guidance 

Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (section III.A of the Repackaging Guidance) .. 6 2 12 3 36 

Total ........................................................................................................................... 8 ............................ 16 .................... 48 

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

Outsourcing facilities submit their 

initial and biannual product reports 

identifying drug products repackaged 

during the previous 6-month period to 

FDA via the Agency’s electronic Drug 

Registration and Listing System as 

explained in the Radiopharmaceutical 

Compounding and Repackaging 

Guidance by Outsourcing Facilities and 

the Repackaging Guidance. We expect to 

receive no waiver requests from the 

electronic submission process for initial 

product reports and semiannual reports. 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Recommended activity; guidance section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average burden 

per recordkeeping 

Total 

hours 

Radiopharmaceutical Compounding and Repackaging Guidance 

Consultation between the compounder and prescriber and the notation 

on the prescription or order documenting the prescriber’s determination of clinical difference (section III.A of the Radiopharmaceutical 

Compounding and Repackaging Guidance).

10 25 250 0.05 (3 minutes) ......... 12.5 


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77530 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Recommended activity; guidance section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average burden 

per recordkeeping 

Total 

hours 

Biological Products Guidance * 

Maintaining records of testing performed in accordance with Appendix A 

of the Biological Products Guidance (section III.B of the Biological 

Products Guidance).

5 30 150 0.083 (5 minutes) ....... 12.5 

Total .................................................................................................... 15 .............................. 400 ..................................... 25 

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

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE 1 2

Recommended activity; guidance section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total 

annual 

disclosures 

Average burden 

per disclosure 

Total 

hours 

Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance 

Designing, testing, and producing each label on immediate containers, 

packages, and/or outer containers (section III.B of the Radiopharmaceutical Compounding and Repackaging Guidance by Outsourcing 

Facilities).

2 5 10 0.5 (30 minutes) ......... 5 

Repackaging Guidance 

Designing, testing, and producing each label on immediate containers, 

packages, and/or outer containers (section III.A of the Repackaging 

Guidance).

6 36 216 1 .................................. 216 

Biological Products Guidance 

Designing, testing, and producing the label, container, packages, and/or 

outer containers for each mixed, diluted, or repackaged biological 

product (section III.B of the Biological Products Guidance).

15 5 75 0.5 (30 minutes) ......... 37.5 

Designing, testing, and producing each label on immediate containers, 

packages, and/or outer containers for each licensed allergenic extract 

(section III.C of the Biological Products Guidance).

5 300 1,500 0.5 (30 minutes) ......... 750 

Total .................................................................................................... 28 .............................. 1,801 ..................................... 1,009 

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

2Totals may not sum due to rounding. 

For purposes of our analysis, we 

characterize the burden associated with 

the time and effort expended on the 

information collection 

recommendations discussed in the 

respective guidance documents as either 

reporting, recordkeeping, or third-party 

disclosure activities. We reconfigured 

the original table by splitting it into 

three tables to better differentiate 

between the estimated annual reporting, 

recordkeeping, and third-party 

disclosure burden. At the same time, 

our findings show that compliance with 

recordkeeping requirements applicable 

to compounded and repackaged drug 

products is standard practice in the 

compounding and selling of these drug 

products under States’ pharmacy laws 

and other State laws governing 

recordkeeping by healthcare 

professionals and healthcare facilities. 

Therefore, we excluded from our 

estimate recordkeeping practices 

discussed in the respective guidance 

documents we consider usual and 

customary. 

For the Repackaging Guidance, to 

correct a clerical error, we have adjusted 

the number of disclosures per 

respondent from 21 to 36 because each 

respondent is estimated to average 6 

different products and average 6 

different strengths, which requires 36 (6 

× 6) unique labels per respondent. The 

initial narrative reflected that each 

product would come in six different 

strengths and thus require six unique 

labels, but due to a clerical error, this 

information was not correctly included 

in the table. We also adjusted the 

number of respondents to six to match 

the number of respondents designing, 

testing, and producing labels. In 

addition, we adjusted the total number 

of disclosures per respondent to two 

given the biannual reporting 

requirement. 

For the Radiopharmaceutical 

Compounding and Repackaging by 

Outsourcing Facilities Guidance, a row 

for biannual product reporting was 

added to capture product reporting that 

was inadvertently omitted. 

Our estimated burden for the 

information collection reflects constant 

respondent numbers. The original 

numbers were based on the information 

the program received from product 

reporting data. We do not have a 

mechanism in place to determine 

whether or not these numbers have 

fluctuated upward or downward; 

however, based on analogous 

observations of industry through 

program experience (some product 

reports), we believe these numbers are 

constant. Repackagers who are also 

registered as outsourcing facilities (OF) 

are not entity types that are individually 

regulated as repackagers. They are 

subsumed in the OF entity type and not 

easily distinguishable. They may or may 

not report their repackaging operations. 

We are updating the information 

collection to include burden attendant 

to reporting and disclosure 

recommendations found in the Agency 

guidance documents that was 

inadvertently omitted in the original 

information collection due to clerical 

errors. The burden estimate is adjusted 


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to reflect a resulting increase of 114 

hours and 94 responses annually. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21676 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4146] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Program 

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 associated with the Agency’s 

Biosimilars User Fee Program. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 22, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 22, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2024–N–4146 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Biosimilars User Fee Program.’’ 

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: 

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, 

including each proposed revision 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 


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