[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75328-75330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26066]


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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.

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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 December 28, 2020.

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: 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, 
[email protected].

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 Agency-sponsored research. 
Drug compounding is generally the practice of combining, mixing, or 
altering ingredients of a drug to create a medication tailored to the 
needs of an individual patient. Although compounded drugs can serve an 
important medical need for certain patients when an approved drug is 
not medically appropriate, they also present a risk to patients. 
Compounded drugs are not FDA-approved. Therefore, they do not undergo 
premarket review by FDA for safety, effectiveness, and quality. Since 
compounded drugs are subject to a lower regulatory standard than 
approved drugs, Federal law places conditions on compounding that are 
designed to protect the public health.
    The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created 
``outsourcing facilities''--a new industry sector of drug compounders 
held to

[[Page 75329]]

higher quality standards to protect patient health. Outsourcing 
facilities are intended to offer a more reliable supply of compounded 
drugs needed by hospitals, clinics, and other providers. Seven years 
since its creation, this domestic industry is still relatively small 
and is experiencing growth and market challenges. In addition, FDA 
continues to find concerning quality and safety problems during 
inspections.
    To help this industry meet its intended function, FDA intends to 
engage in several initiatives to address challenges and support 
compliance and advancement. One initiative includes conducting in-depth 
research to understand better the challenges and opportunities 
encountered by the outsourcing facility sector in a number of different 
areas. These include: Operational barriers and opportunities related to 
the outsourcing facility market and business viability; knowledge and 
operational barriers and opportunities related to compliance with 
Federal policies and good quality drug production; and barriers and 
opportunities related to outsourcing facility interactions with FDA.
    This is an extension of research that began last year. We have 
learned about barriers and opportunities encountered by outsourcing 
facilities in several areas. These include: Operational barriers and 
opportunities related to the outsourcing facility market and business 
viability; knowledge and operational barriers and opportunities related 
to compliance with Federal policies and good quality drug production; 
and barriers and opportunities related to outsourcing facility 
interactions with FDA. We need to extend this information collection 
for two reasons: (1) Based on what we learned, we will want to ask some 
follow up questions in these areas; (2) We received a low response rate 
and need to reach the rest of the outsourcing facility industry. We 
only managed to obtain completed surveys from approximately one third 
of respondents. Only 45 percent of outsourcing facilities provided any 
response to the survey. Therefore, over half of outsourcing facilities 
did not respond to our survey, and we were unable to obtain their 
viewpoints. The results of this research will be used by FDA to develop 
a comprehensive understanding of the outsourcing facility sector, its 
challenges, and opportunities for advancement. The information will be 
essential to help identify knowledge and information gaps, operational 
barriers, and views on interactions with FDA. The research results will 
inform FDA's future approaches to communication, education, training, 
and other engagement with outsourcing facilities to address challenges 
and support advancement.
    Researchers will engage pharmacists, staff, and management from 
outsourcing facilities and similar compounding businesses. Researchers 
may use surveys, interviews, and focus groups to obtain information 
concerning challenges and opportunities encountered by outsourcing 
facilities. Within this context, the following questions or similar, 
related questions may be posed:
    1. What financial and operational considerations inform outsourcing 
facility operational and business model decisions?
    2. What factors impact the development of a sustainable outsourcing 
facility business?
    3. What financial and operational considerations inform outsourcing 
facility product decisions?
    4. Do outsourcing facilities understand the Federal legislative and 
regulatory policies that apply to them? What, if any, knowledge gaps 
need to be addressed?
    5. What challenges do outsourcing facilities face when implementing 
Federal current good manufacturing practice (CGMP) requirements?
    6. How do outsourcing facilities implement quality practices at 
their facilities?
    7. How is CGMP and quality expertise developed by outsourcing 
facilities? How do they obtain this knowledge, and what training do 
they need?
    8. What are the economic consequences of CGMP noncompliance/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 June 18, 2020 (85 FR 36857), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received four comments. Although four 
comments were received, three were not responsive to the four 
collection of information topics solicited and, therefore, will not be 
discussed in this document. The other comment included a number of 
suggested questions to expand upon the questions posed in the 60-day 
notice and, therefore, can be considered ways to enhance the quality, 
utility, and clarity of the information to be collected. While the 
questions will not be included verbatim in our survey instrument, FDA 
will give the questions due consideration as the Agency proceeds with 
this study.
    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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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.


[[Page 75330]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26066 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P