[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Notices]
[Pages 72410-72412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19870]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3762]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Obtaining Information To Understand Challenges and
Opportunities Encountered by Compounding Outsourcing Facilities
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 the information collection
associated with FDA research in obtaining information from pharmacists
and other management at outsourcing facilities and related human
prescription drug compounding businesses. The research supports a
comprehensive analysis of the outsourcing facility sector that informs
ongoing FDA work in this area.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 4, 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 4, 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-3762 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Obtaining Information to
Understand Challenges and Opportunities Encountered by Compounding
Outsourcing Facilities.'' 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
[[Page 72411]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Obtaining Information to Understand Challenges and Opportunities
Encountered by Compounding Outsourcing Facilities
OMB Control Number 0910-0883--Extension
This information collection supports FDA research to obtain
information about challenges and opportunities pertaining to human
prescription drug compounding by outsourcing facilities. Generally,
drug compounding is the practice of combining, mixing, or altering
ingredients of a drug to create a medication tailored to an individual
patient's needs. Although compounded drugs can serve an important
medical need for certain patients when an approved drug is not
medically appropriate, compounded drugs also present a risk to
patients. Compounded drugs are not FDA-approved; therefore, they do not
undergo FDA premarket review for safety, effectiveness, and quality.
Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes the conditions that must be satisfied for
compounded human prescription drug products to be exempt from certain
sections of the FD&C Act: (1) section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (current good manufacturing practice (CGMP)
requirements); (2) section 502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) (labeling of drugs with adequate directions for use); and
(3) section 505 of the FD&C Act (21 U.S.C. 355) (approval of drugs
under new drug applications or abbreviated new drug applications).
The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created
outsourcing facilities--a new industry sector of drug compounders held
to higher quality standards to protect patient health. Section 503B of
the FD&C Act (21 U.S.C. 353b) describes the conditions that outsourcing
facilities must satisfy for drug products compounded in an outsourcing
facility by or under the direct supervision of a licensed pharmacist to
be exempt from the certain sections of the FD&C Act. Outsourcing
facilities are intended to offer a more reliable supply of compounded
drugs that hospitals, clinics, and other providers need.
FDA continues to find concerning quality and safety problems during
inspections of outsourcing facilities. FDA has implemented and will
continue to implement programs to support compounding quality and
compliance. One initiative is FDA's Compounding Quality Center of
Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was
developed to focus on improving the quality of compounded human
prescription drugs to promote patient safety. One of our top priorities
is to help ensure that compounded drugs are safe by focusing on
quality. FDA, state regulators, pharmacy associations, and compounders,
including outsourcing facilities, share the responsibility of patient
safety.
The Center of Excellence engages and collaborates with compounders,
including outsourcing facilities, and other stakeholders to improve the
overall quality of compounded drugs. Furthermore, the Center of
Excellence promotes collaboration to help compounders implement robust
quality management systems that are better for business and the safety
of patients.
In addition, the Center of Excellence is conducting in depth
research to better understand outsourcing facilities' challenges and
opportunities in different areas to help guide decisions regarding
future training and other engagement. Outsourcing facilities encounter
the following challenges and opportunities: (1) operational barriers
and opportunities related to the outsourcing facility market and
business viability; (2) knowledge and operational barriers and
opportunities related to compliance with Federal policies and good
quality drug production; and (3) barriers and opportunities related to
outsourcing facility interactions with FDA.
FDA used previous research results under this information
collection to develop an understanding of the outsourcing facility
sector, the sector's challenges, and opportunities for advancement. The
information collected was an essential tool to help FDA identify
knowledge and information gaps, operational barriers, and views on
interactions with FDA. FDA has presented this information in public
settings such as stakeholder meetings.
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Continuing this collection will enable FDA to deepen our understanding
of the outsourcing facility sector and increase our efficacy in
developing a Center of Excellence that is responsive to outsourcing
facilities' needs. The research results will inform FDA's future
activities for the Center of Excellence in the areas of communication,
education, training, and other engagement with outsourcing facilities
to address challenges and support advancement.
Researchers engage with pharmacists, staff, and management from
outsourcing facilities and similar compounding businesses, and related
stakeholders and use surveys to obtain information about outsourcing
facilities' challenges and opportunities. Within this context, we may
pose the following questions or similar, related questions:
1. What financial and operational considerations inform outsourcing
facility operational and business model decisions?
2. What factors impact developing a sustainable outsourcing
facility business?
3. What financial and operational considerations inform outsourcing
facility product decisions?
4. Do outsourcing facilities understand the Federal laws and
policies that apply to them? What, if any, knowledge gaps do we need to
address?
5. What are outsourcing facilities' challenges when implementing
Federal CGMP requirements?
6. How do outsourcing facilities implement quality practices at
their facilities?
7. How do outsourcing facilities develop CGMP and quality
expertise? How do they obtain this knowledge, and what training do they
need?
8. What are the economic consequences of CGMP noncompliance and
product failures for outsourcing facilities?
9. What are outsourcing facility management and staff views on
current interactions with FDA? How do they want the interactions to
change?
10. What are outsourcing facilities' understanding of how to engage
with FDA during and following an inspection?
Respondents to this information collection are employees at
outsourcing facilities and related human prescription drug compounding
businesses.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Survey Invitation............... 250 1 250 0.0833 21
(5 mins)
Survey Questionnaire............ 250 1 250 0.75 188
(45 mins)
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Total....................... .............. .............. 500 .............. 209
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The universe of registered outsourcing facilities and related human
prescription drug compounding businesses known to the Center of
Excellence will be sent a survey invitation. We reduced our estimate of
the number of respondents from 300 to 250. We estimate that
approximately 250 respondents will receive an invitation to participate
in the survey and will spend 5 minutes reading the invitation and
considering whether to take the survey, for a total of 20.825 burden
hours per year, rounded to 21 hours. Based on our historical
experience, we anticipate that all those invited to participate in the
survey will complete the survey. We anticipate a slight reduction in
burden hours to 45 minutes (0.75 hour) per survey response from our
previous estimate of 1 hour per response. We estimate that
approximately 250 respondents will spend 45 minutes completing the
survey, for a total of 187.5 burden hours per year, rounded to 188
hours.
Based on a review of the information collection since our last
request for OMB approval, we have made adjustments to our burden
estimate. Our estimated burden for the information collection reflects
an overall decrease of 391 hours and a corresponding decrease of 100
responses. We have also reduced our estimated burden per survey
response from 1 hour to 45 minutes.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19870 Filed 9-4-24; 8:45 am]
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