[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68462-68463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27053]


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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 (PRA).

DATES: Fax written comments on the collection of information by January 
15, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Obtaining Information to Understand Challenges and 
Opportunities Encountered by Compounding Outsourcing Facilities''. 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, 
PRAStaff@fda.hhs.gov.

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-NEW

    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 created ``outsourcing 
facilities''--a new industry sector of drug compounders held to higher 
quality standards to protect patient health. Outsourcing facilities are 
intended to offer a more reliable supply of

[[Page 68463]]

compounded drugs needed by hospitals, clinics, and other providers. 
Five 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 better understand 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.
    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 non-compliance/
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 July 29, 2019 (84 FR 36609), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, one was 
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.

    We base our estimate of the average burden per response on review 
activities familiar to the Agency.

    Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27053 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P


