[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Pages 36609-36611]
[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

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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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?

                                                     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


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73158]
[DOCID:fr29no10-153]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257; Notice No. 64]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Announcement of Railroad Safety Advisory Committee (RSAC)
Meeting.

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SUMMARY: FRA announces the forty-third meeting of the RSAC, a Federal
advisory committee that develops railroad safety regulations through a
consensus process. The RSAC meeting topics will include opening remarks
from the FRA Administrator, and status reports will be provided by the
Passenger Hours of Service, Training Standards, Track Safety Standards,
Passenger Safety, and Medical Standards Working Groups. Further
discussions will also be held on the previously accepted RSAC Task 10-
02 regarding the Development, Use, and Implementation of Rail Safety
Technology in Dark Territory. This agenda is subject to change,
including the possible addition of further proposed tasks under the
Rail Safety Improvement Act of 2008.

DATES: The meeting of the RSAC is scheduled to commence at 9:30 a.m. on
Tuesday, December 14, 2010, and will adjourn by 4:30 p.m.

ADDRESSES: The RSAC meeting will be held at the National Association of
Home Builders National Housing Center, 1201 15th Street, NW.,
Washington, DC 20005. The meeting is open to the public on a first-
come, first-served basis, and is accessible to individuals with
disabilities. Sign and oral interpretation can be made available if
requested 10 calendar days before the meeting.

FOR FURTHER INFORMATION CONTACT: Larry Woolverton, RSAC Administrative
Officer/Coordinator, FRA, 1200 New Jersey Avenue, SE., Mailstop 25,
Washington, DC 20590,<PHONE_NUMBER>; or Robert Lauby, Deputy Associate
Administrator for Regulatory and Legislative Operations, FRA, 1200 New
Jersey Avenue, SE., Mailstop 25, Washington, DC 20590,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC. The RSAC was established to provide advice and
recommendations to FRA on railroad safety matters. The RSAC is composed
of 54 voting representatives from 31 member organizations, representing
various rail industry perspectives. In addition, there are non-voting
advisory representatives from the agencies with railroad safety
regulatory responsibility in Canada and Mexico, the National
Transportation Safety Board, and the Federal Transit Administration.
The diversity of the Committee ensures the requisite range of views and
expertise necessary to discharge its responsibilities. See the RSAC Web
site for details on prior RSAC activities and pending tasks at: http://
rsac.fra.dot.gov/. Please refer to the notice published in the Federal
Register on March 11, 1996 (61 FR 9740), for additional information
about the RSAC.

    Issued in Washington, DC, on November 22, 2010.
Robert C. Lauby,
Deputy Associate Administrator for Regulatory and Legislative
Operations.
[FR Doc. 2010-29870 Filed 11-26-10; 8:45 am]
BILLING CODE 4910-06-P