Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities, 36609-36611 [2019-16027]
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Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices
prevention of delayed graft function in
kidney transplantation. 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. This
guidance is not subject to Executive
Order 12866.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information under 21 CFR part 312
(investigational new drug application
regulations) have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
parts 50 and 56 (Protection of Human
Subjects: Informed Consent;
Institutional Review Boards) have been
approved under OMB control number
0910–0755. The collection of
information under 21 CFR part 314,
including the submission of information
under subpart H (accelerated approval),
has been approved under OMB control
number 0910–0001. The collection of
information under the guidance for
industry entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ (available at https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm358301.pdf) has been
approved under OMB control number
0910–0765.
III. Electronic Access
khammond on DSKBBV9HB2PROD with NOTICES
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16026 Filed 7–26–19; 8:45 am]
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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.
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.
SUMMARY:
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
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36609
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
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36610
Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices
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/201523389.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
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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
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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 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?
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Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices
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: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16027 Filed 7–26–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–2559]
Determination That FORTAMET
(Metformin Hydrochloride) ExtendedRelease Tablets, 500 Milligrams and 1
Gram, Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that FORTAMET
(metformin hydrochloride) extendedrelease tablets, 500 milligrams (mg) and
1 gram (g), were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to these products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
khammond on DSKBBV9HB2PROD with NOTICES
Carlarease Hunter, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–3702, Carlarease.Hunter@
fda.hhs.gov.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
SUPPLEMENTARY INFORMATION:
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must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, are the subject of NDA
021574, held by Andrx Labs, LLC, and
initially approved on April 27, 2004.
FORTAMET is indicated as an adjunct
to diet and exercise to improve glycemic
control in adults with type 2 diabetes
mellitus.
FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. Ajanta
Pharma Limited submitted a citizen
petition dated May 27, 2019 (Docket No.
FDA–2019–P–2559), under 21 CFR
10.30, requesting that the Agency
determine whether FORTAMET
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(metformin hydrochloride) extendedrelease tablets, 500 mg and 1 g, were
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that FORTAMET
(metformin hydrochloride) extendedrelease tablets, 500 mg and 1 g, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
FORTAMET (metformin hydrochloride)
extended-release tablets, 500 mg and 1
g, from sale. We have also
independently evaluated relevant
literature and data for possible post
marketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of approved ANDAs that refer
to this drug product. Additional ANDAs
for this drug product may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16008 Filed 7–26–19; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: 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
