Notice2021-28465
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 2 (Tuesday, January 4, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 2 (Tuesday, January 4, 2022)]
[Notices]
[Pages 228-229]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28465]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3077]
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.
-----------------------------------------------------------------------
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 February 3, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
<a href="/cdn-cgi/l/email-protection#dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="fbaba9baa88f9a9d9dbb9d9f9ad5939388d59c948d">[email protected]</span></a>.
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.
Obtaining Information To Understand Challenges and Opportunities
Encountered by Compounding Outsourcing Facilities
OMB Control Number 0910-0883--Extension
This information collection supports FDA research in obtaining a
range of information 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) (21 U.S.C.
351(a)(2)(B)) (current good manufacturing practice (CGMP)
requirements), (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of
drugs with adequate directions for use), and (3) section 505 (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 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), <a href="https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence">https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence</a>, 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 for 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.
To help strengthen the outsourcing facility industry's ability to
provide quality compounded drugs to patients who need them, the Center
of Excellence offers training sessions and opportunities to develop
manufacturing quality and other policies for outsourcing facilities,
including CGMPs.
The Center of Excellence offers several training sessions
(available at <a href="https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence">https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence</a>-training-programs). Self-guided
training sessions teach the following topics: (1) Environmental
monitoring, (2) sterile drug compounding, (3) cleanroom performance
tests, and (4) conducting investigations and formulating corrective and
preventive actions. Instructor-led sessions teach the regulatory
framework for these topics: (1) Human drug compounding, (2) airflow
practices, (3) insanitary conditions and sterility, (4) stability and
beyond use dates, (5) requirements for outsourcing facility guides, and
(6) conducting investigations and formulating corrective and preventive
actions. Management and staff from outsourcing facilities have attended
the training sessions. Feedback on the training sessions has been
positive, and interest in the sessions continues to grow.
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
[[Page 229]]
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.
Researchers engage with pharmacists, staff, management from
outsourcing facilities, similar compounding businesses, and related
stakeholders and may use surveys, interviews, and focus groups 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?
In the Federal Register of October 1, 2021 (86 FR 54450), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment from an industry
association relating to the quality of questions previously posed to
industry stakeholders concerning outsourcing facilities. Specifically,
the commenter stated that the proposed questions included in the 60-day
notice were insufficient to fully acquire information relating to the
challenges and opportunities outsourcing facilities face. Accordingly,
the commenter provided a number of additional questions for FDA to use,
which the commenter believes will better solicit relevant information.
FDA has considered the commenter's additional questions and will take
them under advisement for possible inclusion in future studies.
However, at this time FDA will not include the commenter's questions in
this particular study because we believe the proposed questions listed
in the 60-day notice will sufficiently solicit the specific information
we are currently seeking.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveys, focus groups, and interviews.............................. 300 2 600 1 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our original request for the information collection was approved
January 21, 2020; however, the subsequent public health emergency
inhibited our ability to administer the requested survey. We have
therefore made no adjustments to our current burden estimate.
Dated: December 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28465 Filed 1-3-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 4, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.