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, 68462-68463 [2019-27053]
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Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Radiological Health oversight, which are
not addressed in section 507.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Qualification Process for Drug
Development Tools.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection that is subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The information collection has
been approved under OMB control
numbers 0910–0001 and 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26994 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
BEOVU (brolucizumab-dbll), approved
October 7, 2019, meets the redemption
criteria.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that BEOVU
(brolucizumab-dbll), approved October
7, 2019, meets the redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsfor
RareDiseasesConditions/
RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about BEOVU
(brolucizumab-dbll), approved October
7, 2019, go to the ‘‘Drugs@FDA’’ website
at https://www.accessdata.fda.gov/
scripts/cder/daf/.
Dated: December 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27054 Filed 12–13–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–N–1262]
Food and Drug Administration
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
[Docket No. FDA–2019–N–3077]
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA),
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
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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.
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
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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
E:\FR\FM\16DEN1.SGM
16DEN1
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
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?
68463
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 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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Surveys, focus groups, and interviews ................................
300
2
600
1
600
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Guidance for Cocaine
Hydrochloride; Nasal Solution; New
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
lotter on DSKBCFDHB2PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a new
draft guidance for industry, entitled
‘‘Draft Guidance for Cocaine
SUMMARY:
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19:21 Dec 13, 2019
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Hydrochloride.’’ The new draft
guidance, when finalized, will provide
product-specific recommendations on,
among other things, the information and
data needed to demonstrate
bioequivalence (BE) to support
abbreviated new drug applications
(ANDAs) for a cocaine hydrochloride
nasal solution.
Submit either electronic or
written comments on the draft guidance
by February 14, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
DATES:
ADDRESSES:
You may submit comments
as follows:
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[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-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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surveys, focus groups, and interviews.............................. 300 2 600 1 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
