[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Pages 36609-36611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16027]


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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 or Agency) 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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on information collection associated with FDA 
research in obtaining information from pharmacists and other management 
at outsourcing facilities as well as at related compounding businesses 
to support a comprehensive analysis of the outsourcing facility sector 
that will inform future FDA work in this area.

DATES: Submit either electronic or written comments on the collection 
of information by September 27, 2019.

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 September 27, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. midnight Eastern Time at the end of September 27, 2019. 
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 ``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.
     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

[[Page 36610]]

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.gpo.gov/fdsys/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.

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. 3501-3520), 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 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-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 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?

[[Page 36611]]



                                                     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: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16027 Filed 7-26-19; 8:45 am]
 BILLING CODE 4164-01-P


