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, 77528-77531 [2024-21676]
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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
OMB
Control No.
21 CFR part; guidance; or FDA form
Topic
‘‘The Accreditation Scheme for Conformity Assessment
(ASCA) Program’’.
807, subpart E ....................................................................
814, subparts A through E .................................................
814, subpart H ....................................................................
812 ......................................................................................
860, subpart D ....................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program’’.
803 ......................................................................................
ASCA Program .....................................................................................
0910–0889
Premarket notification ...........................................................................
Premarket approval ..............................................................................
Humanitarian Device Exemption ..........................................................
Investigational Device Exemption ........................................................
De Novo classification process ............................................................
Q-submissions ......................................................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
0910–0756
Medical Devices; Medical Device Reporting; Manufacturer reporting,
importer reporting, user facility reporting, distributor reporting.
Current Good Manufacturing Practice (CGMP); Quality System (QS)
Regulation.
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.
0910–0437
820 ......................................................................................
58 ........................................................................................
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
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.
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.
SUMMARY:
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.
ADDRESSES:
[FR Doc. 2024–21673 Filed 9–20–24; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
information in the following table have
been approved by OMB:
Human Drug Compounding,
Repackaging, and Related Activities
Regarding Sections 503A and 503B of
the Federal Food, Drug, and Cosmetic
Act
0910–0073
0910–0119
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:
OMB Control Number 0910–0858—
Extension
This information collection helps
support implementation of sections
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).
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September 26, 2018 (83 FR 48633).
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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).
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (Repackaging
Guidance) (available at https://www.fda.gov/media/90978/download).
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).
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
September 26, 2018 (83 FR 48630).
January 13, 2017 (82 FR 4343).
January 19, 2018 (83 FR 2787).
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
Number of
respondents
Recommended activity; guidance section
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
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
Repackaging Guidance
1 There
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
Number of
recordkeepers
Recommended activity; guidance section
Number of
records per
recordkeeper
Total
annual
records
Average burden
per recordkeeping
Total
hours
Radiopharmaceutical Compounding and Repackaging Guidance
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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).
1 Guidance documents applicable to animal drug
compounding regulated by the Center for Veterinary
Medicine would also be returned if no FDA
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10
25
Organization is selected; this information collection
covers only those compounding guidance
documents issued by the Center for Drug Evaluation
PO 00000
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250
0.05 (3 minutes) .........
12.5
and Research and Center for Biologics Evaluation
and Research.
E:\FR\FM\23SEN1.SGM
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
records per
recordkeeper
Number of
recordkeepers
Recommended activity; guidance section
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
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE 1 2
Number of
disclosures per
respondent
Number of
respondents
Recommended activity; guidance section
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
36
216
1 ..................................
216
Repackaging Guidance
Designing, testing, and producing each label on immediate containers,
packages, and/or outer containers (section III.A of the Repackaging
Guidance).
6
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
28
..............................
1,801
.....................................
1,009
Total ....................................................................................................
1 There
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2 Totals
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
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16:57 Sep 20, 2024
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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.
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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
E:\FR\FM\23SEN1.SGM
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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.
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.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:57 Sep 20, 2024
Jkt 262001
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
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77531
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-201509-18/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
E:\FR\FM\23SEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77528-77531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21676]
-----------------------------------------------------------------------
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,
[email protected].
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 September 26, 2018 (83 FR 48633).
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 102615/download).
[[Page 77529]]
Compounding and Repackaging of Radiopharmaceuticals September 26, 2018 (83 FR 48630).
by Outsourcing Facilities (Radiopharmaceutical
Compounding and Repackaging by Outsourcing
Facilities Guidance) (available at https://www.fda.gov/media/102637/download).
Repackaging of Certain Human Drug Products by January 13, 2017 (82 FR 4343).
Pharmacies and Outsourcing Facilities (Repackaging
Guidance) (available at https://www.fda.gov/media/90978/download 90978/download).
Mixing, Diluting, or Repackaging Biological Products January 19, 2018 (83 FR 2787).
Outside the Scope of an Approved Biologics License
Application (Biological Products Guidance)
(available at https://www.fda.gov/media/90986/download download).
----------------------------------------------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Recommended activity; guidance section Number of disclosures per Total annual burden per Total
respondents respondent disclosures disclosure hours
----------------------------------------------------------------------------------------------------------------
Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
----------------------------------------------------------------------------------------------------------------
Biannual product reports identifying drug 2 2 4 3 12
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
----------------------------------------------------------------------------------------------------------------
Biannual product reports identifying drug 6 2 12 3 36
products repackaged by the outsourcing
facility during the previous 6-month
period (section III.A of the Repackaging
Guidance)................................
---------------------------------------------------------------------
Total................................. 8 ................ 16 ........... 48
----------------------------------------------------------------------------------------------------------------
\1\ There 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Total
Recommended activity; guidance section recordkeepers per recordkeeper records Average burden per recordkeeping hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Radiopharmaceutical Compounding and Repackaging Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the compounder and 10 25 250 0.05 (3 minutes).......................... 12.5
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).
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 77530]]
Biological Products Guidance *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintaining records of testing performed in 5 30 150 0.083 (5 minutes)......................... 12.5
accordance with Appendix A of the Biological
Products Guidance (section III.B of the
Biological Products Guidance).
--------------------------------------------------------------------------------------------------------
Total...................................... 15 ................. 400 .......................................... 25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 4--Estimated Annual Third-Party Disclosure 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Recommended activity; guidance section Number of disclosures per Total annual Average burden per disclosure Total
respondents respondent disclosures hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each label on 2 5 10 0.5 (30 minutes).......................... 5
immediate containers, packages, and/or outer
containers (section III.B of the
Radiopharmaceutical Compounding and
Repackaging Guidance by Outsourcing
Facilities).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Repackaging Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each label on 6 36 216 1......................................... 216
immediate containers, packages, and/or outer
containers (section III.A of the Repackaging
Guidance).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biological Products Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing the label, 15 5 75 0.5 (30 minutes).......................... 37.5
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 producing each label on 5 300 1,500 0.5 (30 minutes).......................... 750
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
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 x 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
[[Page 77531]]
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
