Notice2021-21382
Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
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Published
October 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 requests 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.
Full Text
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54450-54453]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21382]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3077]
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 requests 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: Submit either electronic or written comments on the collection
of information by November 30, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 30, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
[[Page 54451]]
comments until 11:59 p.m. Eastern Time at the end of November 30, 2021.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2019-N-3077 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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#c9999b889abda8afaf89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="76262437250217101036101217581e1e0558111900">[email protected]</span></a>.
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 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 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))
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(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 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), <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 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.
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 indepth
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.
Researchers engage with pharmacists, staff, and management from
outsourcing facilities and similar compounding businesses 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?
FDA estimates the burden of this collection of information as
follows:
[[Page 54453]]
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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Surveys, focus groups, and interviews.............................. 300 2 600 1 600
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\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: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21382 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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