[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18663-18665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07557]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3762]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 June 2, 2025.
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 0910-0883. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA
[[Page 18664]]
has submitted the following proposed collection of information to OMB
for review and clearance.
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. 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.
We revised the survey to improve clarity and simplify the
experience for participants. We made grammatical, stylistic, format,
and other editorial changes to the content. In doing so, we reduced the
number of questions from 31 to 20. We anticipate a reduction in burden
hours to 30 minutes (.50 hour) per survey response from our previous
estimate of 1 hour per response.
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.
In the Federal Register of September 5, 2024 (89 FR 72410), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received four comment letters from trade
organizations and
[[Page 18665]]
industry, each containing one or more comments on the proposed
collection of information.
(Comment 1) Several comments expressed appreciation for FDA's
efforts in developing a comprehensive understanding of the outsourcing
facility sector, its challenges, and opportunities for advancement.
Other comments expressed appreciation for FDA's efforts to ensure that
the survey questions capture the most important information from
compounding outsourcing facilities and that the survey not place an
undue burden on respondents.
(Response 1) We agree that the information being collected has
utility for understanding of the outsourcing facility sector, its
challenges, and opportunities for advancement and that we are making an
effort to not place an undue burden on respondents.
(Comment 2) One comment suggested that certain questions focus on
financial considerations and economic consequences and argued that they
are not necessary for FDA's oversight of outsourcing facilities and are
unrelated to FDA's public health mission and the quality and safety of
compounded drugs.
(Response 2) We have considered the comments and disagree. As
stated previously, the Center of Excellence is conducting this research
to better understand outsourcing facilities' challenges and
opportunities in different areas to help guide decisions regarding
future training and other engagement. We think that an important
component to understanding the challenges and opportunities that
outsourcing facilities face includes gaining insight into the financial
considerations that impact outsourcing facilities' operations and
business models.
(Comment 3) Several comments proposed changes to existing questions
or the inclusion of new questions.
(Response 3) We have considered the comments requesting that the
Agency update the questionnaire and disagree that certain questions
should be modified or added. We believe that the information sought
from the proposed questions will be captured within the existing
questions or elsewhere in our research.
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 per response Total hours
respondents respondent responses
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Survey Invitation........................... 250 1 250 0.0833 (5 mins)........................... 21
Survey Questionnaire........................ 250 1 250 0.50 (30 mins)............................ 125
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Total................................... .............. .............. 500 .......................................... 146
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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 estimate that respondents will
spend 15 to 30 minutes to complete the revised survey. Using the upper-
bound estimate, we report a reduction in burden hours to 30 minutes
(0.50 hour) per survey response from our previous estimate of 1 hour
per response. We estimate that approximately 250 respondents will spend
30 minutes completing the survey, for a total of 146 burden hours per
year.
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 454 hours and a corresponding decrease of 100
responses. We have also reduced our estimated burden per survey
response from 1 hour to 30 minutes.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07557 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P