[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54450-54453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov electronic filing system will accept

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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:
     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-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 
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 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: 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, 
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 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), 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.
    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 https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-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:

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                                                     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


