[Federal Register Volume 89, Number 114 (Wednesday, June 12, 2024)]
[Notices]
[Pages 49880-49884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2583]


Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with Agency guidance documents pertaining to pharmacies, 
outsourcing facilities, and other entities with regard to human drug 
compounding, repackaging, and related activities.

DATES: Either electronic or written comments on the collection of 
information must be submitted by August 12, 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 August 12, 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-2583 for ``Human Drug Compounding, Repackaging, and Related 
Activities Regarding Sections 503A and 503B of the Federal Food, Drug, 
and Cosmetic Act.'' 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

[[Page 49881]]

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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[email protected].

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.

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

I. Background

    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.

II. Guidances

    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
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                                                  Notice of availability
                      Title                          publication date
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Compounding and Repackaging of                    September 26, 2018 (83
 Radiopharmaceuticals by State-Licensed Nuclear    FR 48633).
 Pharmacies, Federal Facilities, and Certain
 Other Entities (Radiopharmaceutical Compounding
 and Repackaging Guidance) (available at https://www.fda.gov/media/102615/download).
Compounding and Repackaging of                    September 26, 2018 (83
 Radiopharmaceuticals by Outsourcing Facilities    FR 48630).
 (Radiopharmaceutical Compounding and
 Repackaging by Outsourcing Facilities Guidance)
 (available at https://www.fda.gov/media/102637/download download).
Repackaging of Certain Human Drug Products by     January 13, 2017 (82
 Pharmacies and Outsourcing Facilities             FR 4343).
 (Repackaging Guidance) (available at https://www.fda.gov/media/90978/download).
Mixing, Diluting, or Repackaging Biological       January 19, 2018 (83
 Products Outside the Scope of an Approved         FR 2787).
 Biologics License Application (Biological
 Products Guidance) (available at https://www.fda.gov/media/90986/download).
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    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

[[Page 49882]]

``Compounding'' from among the possible Filters.\1\
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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.
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A. Radiopharmaceutical Compounding and Repackaging Guidance

    Because Congress explicitly excluded radiopharmaceuticals from 
section 503A of the FD&C Act (see section 503A(d)(2)), compounded 
radiopharmaceuticals are not eligible for the exemptions under section 
503A from section 505 of the FD&C Act (21 U.S.C. 355) (concerning new 
drug approval requirements), section 502(f)(1) of the FD&C Act (21 
U.S.C. 352(f)(1)) (concerning labeling with adequate directions for 
use), and section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)B)) 
(concerning current good manufacturing practice (CGMP) requirements). 
In addition, the FD&C Act does not provide an exemption for repackaged 
radiopharmaceuticals. The guidance describes the conditions under which 
FDA does not intend to take action for violations of sections 505, 
502(f)(1), and 501(a)(2)(B) of the FD&C Act when a State-licensed 
nuclear pharmacy, Federal facility, or other facility that is not an 
outsourcing facility and that holds a radioactive materials license for 
medical use issued by the Nuclear Regulatory Commission or by an 
Agreement State compounds or repackages radiopharmaceuticals for human 
use. The guidance explains that one condition is that the compounded 
radiopharmaceutical is not essentially a copy of an approved 
radiopharmaceutical. As described in the guidance, FDA does not intend 
to consider a compounded radiopharmaceutical to be essentially a copy 
if, among other reasons, there is a change between the compounded 
radiopharmaceutical and the approved radiopharmaceutical that produces 
a clinical difference for an identified individual patient, as 
determined by the prescribing practitioner and documented in writing on 
the prescription or order. In addition, FDA does not intend to consider 
a compounded radiopharmaceutical to be essentially a copy if the FDA-
approved radiopharmaceutical is on FDA's drug shortage list (see 
section 506E of the FD&C Act (21 U.S.C. 356e)) at the time of 
compounding and distribution. If the facility compounded a drug that is 
identical or nearly identical to an approved drug product that appeared 
on FDA's drug shortage list, the facility should maintain documentation 
(e.g., a notation on the order for the compounded drug) regarding the 
status of the drug on FDA's drug shortage list at the time of 
compounding, distribution, and dispensing.

B. Radiopharmaceutical Compounding and Repackaging by Outsourcing 
Facilities Guidance

    In contrast to section 503A, section 503B of the FD&C Act does not 
exclude radiopharmaceuticals. Therefore, FDA's overall policies 
regarding section 503B of the FD&C Act apply to the compounding of 
radiopharmaceuticals. However, we have developed specific policies that 
apply only to the compounding of radiopharmaceuticals by outsourcing 
facilities using bulk drug substances and to the compounding of 
radiopharmaceuticals by outsourcing facilities that are essentially 
copies of approved drugs when such compounding is limited to minor 
deviations, as that term is defined in the guidance. FDA issued this 
guidance in part to describe the conditions under which the Agency does 
not generally intend to take action for violations of sections 505 and 
502(f)(1) of the FD&C Act when an outsourcing facility repackages 
radiopharmaceuticals for human use.
    As discussed in the guidance, one condition is that if a 
radiopharmaceutical is repackaged by an outsourcing facility, the label 
on the immediate container (primary packaging, e.g., the syringe) of 
the repackaged product includes certain information.

C. Repackaging Guidance

    The guidance describes the conditions under which FDA does not 
intend to take action for violations of sections 505 (concerning new 
drug applications), 502(f)(1) (concerning labeling with adequate 
directions for use), 582 ((21 U.S.C. 360eee-1) concerning drug supply 
chain security requirements), and (where specified in the guidance) 
501(a)(2)(B) of the FD&C Act (concerning CGMPs), when a State-licensed 
pharmacy, Federal facility, or outsourcing facility repackages certain 
prescription drugs. One condition discussed in the guidance is that if 
a drug is repackaged by an outsourcing facility, the label on the 
immediate container (primary packaging, e.g., the syringe) of the 
repackaged product includes certain information described in the 
guidance.
    Conditions discussed in the guidance include that if a drug is 
repackaged by an outsourcing facility, the label on the immediate 
container (primary packaging, e.g., the syringe) and on the container 
from which the individual units are removed for administration 
(secondary packaging, e.g., the bag, box, or other package in which the 
repackaged products are distributed) of the repackaged product include 
certain information described in the guidance.

D. Biological Products Guidance

    Certain licensed biological products may sometimes be mixed, 
diluted, or repackaged in a way not described in the approved labeling 
for the product to meet the needs of a specific patient. As described 
in the guidance, biological products subject to licensure under section 
351 of the Public Health Service (PHS) Act (42 U.S.C. 262) are not 
eligible for the statutory exemptions available to certain compounded 
drugs under sections 503A and 503B of the FD&C Act. In addition, a 
biological product that is mixed, diluted, or repackaged outside the 
scope of an approved biologics license application (BLA) is considered 
an unlicensed biological product under section 351 of the PHS Act.
    This guidance document describes several conditions under which FDA 
does not intend to take action for violations of section 351 of the PHS 
Act and sections 502(f)(1), 582, and (where specified) 501(a)(2)(B) of 
the FD&C Act, when a State-licensed pharmacy, a Federal facility, or an 
outsourcing facility dilutes, mixes, or repackages certain biological 
products outside the scope of an approved BLA.
    One condition discussed in the guidance is that if the labeling for 
the licensed biological product includes storage instructions, handling 
instructions, or both (e.g., protect from light, do not freeze, keep at 
specified storage temperature), the labeling for the biological product 
that is mixed, diluted, or repackaged specifies the same storage 
conditions. Another condition described in the guidance is that, if the 
biological product is mixed, diluted, or repackaged by an outsourcing 
facility, the label on the immediate container (primary packaging, 
e.g., the syringe) of the mixed, diluted, or repackaged product 
includes certain information described in the guidance. In addition, 
the guidance communicates that as a condition for biological products 
mixed, diluted, or repackaged by an outsourcing facility that, if the 
immediate product label is too small to bear the active and inactive 
ingredients, such information is included on the label of the container 
from which the

[[Page 49883]]

individual units are removed for administration (secondary packaging, 
e.g., the bag, box, or other package in which the mixed, diluted, or 
repackaged biological products are distributed).
    The guidance also communicates FDA's thinking about the condition 
for biological products mixed, diluted, or repackaged by an outsourcing 
facility that the label on the container from which the individual 
units are removed for administration include directions for use. These 
directions include, as appropriate, the dosage and administration and 
the following information to facilitate adverse event reporting: 
https://www.fda.gov/medwatch and 1-800-FDA-1088.
    Finally, another condition described in the guidance is that 
outsourcing facilities maintain records of the testing performed in 
accordance with ``Appendix A--Assigning a BUD for Repackaged Biological 
Products Based on Stability Testing'' of the guidance for biological 
products repackaged by outsourcing facilities for which the beyond use 
date (BUD) is established based on a stability program conducted in 
accordance with Appendix A.
    Section III.C of the guidance, ``Licensed Allergenic Extracts for 
Subcutaneous Immunotherapy,'' discusses the preparation of prescription 
sets (i.e., licensed allergenic extracts that are mixed and diluted to 
provide subcutaneous immunotherapy to an individual patient) by a 
physician, a State-licensed pharmacy, a Federal facility, or an 
outsourcing facility. Another condition described in the guidance is 
that if the prescription set is prepared by an outsourcing facility, 
the label of the container from which the individual units of the 
prescription set are removed for administration (secondary packaging) 
includes the following information to facilitate adverse event 
reporting: https://www.fda.gov/medwatch and 1-800-FDA-1088. Each 
prescription set prepared by an outsourcing facility is also 
accompanied by instructions for use.

III. Electronic Product Reporting to FDA

    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 (eDRLS) as explained in the Radiopharmaceutical 
Compounding and Repackaging Guidance by Outsourcing Facilities and the 
Repackaging Guidance. Also, we expect to receive no waiver requests 
from the electronic submission process for initial product reports and 
semiannual reports.
    We estimate the burden of this information collection as follows:

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                 Number of
    Recommended activity;        Number of      records per     Total annual    Average burden per   Total hours
      guidance section         recordkeepers    recordkeeper       records         recordkeeping
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                            Radiopharmaceutical Compounding and Repackaging Guidance
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Consultation between the                  10               25             250  .05 (3 minutes).....         12.5
 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).
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                                          Biological Products Guidance
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Maintaining records of                     5               30             150  0.083 (5 minutes)...         12.5
 testing performed in
 accordance with Appendix A
 of the Biological Products
 Guidance (section III.B of
 the Biological Products
 Guidance).
                             -----------------------------------------------------------------------------------
    Total...................              15  ...............             400  ....................          25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                              Table 3--Estimated Annual Third-Party Disclosure 1 2
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                                                 Number of
    Recommended activity;        Number of    disclosures per   Total annual    Average burden per   Total hours
      guidance section          respondents      respondent      disclosures        disclosure
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               Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
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Designing, testing, and                    2                5              10  0.5 (30 minutes)....            5
 producing each label on
 immediate containers,
 packages, and/or outer
 containers (section III.B
 of the Radiopharmaceutical
 Compounding and Repackaging
 Guidance by Outsourcing
 Facilities).
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                                              Repackaging Guidance
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Designing, testing, and                    6               36             216  1...................          216
 producing each label on
 immediate containers,
 packages, and/or outer
 containers (section III.A
 of the Repackaging
 Guidance).
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                                          Biological Products Guidance
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Designing, testing, and                   15                5              75  0.5 (30 minutes)....         37.5
 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).
Designing, testing, and                    5              300           1,500  0.5 (30 minutes)....          750
 producing each label on
 immediate containers,
 packages, and/or outer
 containers for each
 licensed allergenic extract
 (section III.C of the
 Biological Products
 Guidance).
                             -----------------------------------------------------------------------------------
    Total...................              28  ...............           1,801  ....................       1,009
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.


[[Page 49884]]


                                 Table 4--Estimated Annual Reporting Burden \1\
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                                                      Number of
  Recommended activity; guidance      Number of    disclosures per   Total annual    Average burden  Total hours
             section                 respondents      respondent      disclosures    per disclosure
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               Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
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Biannual product reports                        2                2               4                3           12
 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).....................
----------------------------------------------------------------------------------------------------------------
                                              Repackaging Guidance
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Biannual product reports                        6                2              12                3           36
 identifying drug products
 repackaged by the outsourcing
 facility during the previous 6-
 month period (section III.A of
 the Repackaging Guidance).......
                                  ------------------------------------------------------------------------------
    Total........................               8  ...............              16  ...............          48
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 recordkeeping, reporting, or third-party disclosure activities. 
We reconfigured the original table by splitting it into three tables to 
better differentiate between the estimated annual recordkeeping burden, 
the estimated annual reporting burden, and the estimated annual 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. We invite comment on this assumption.
    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 x 6) unique labels 
per respondent. The initial narrative reflected that each product would 
come in 6 different strengths and thus require 6 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 6 to match the 
number of respondents designing, testing, and producing labels. In 
addition, we adjusted the total number of disclosures per respondent to 
2 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 to reflect a resulting increase of 114 hours and 
94 responses annually.

    Dated: June 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12783 Filed 6-11-24; 8:45 am]
BILLING CODE 4164-01-P