Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities, 54450-54453 [2021-21382]
Download as PDF
<![CDATA[
54450
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
FOR FURTHER INFORMATION CONTACT:
Natalie Grant, Director, Office of Human
Services Emergency Preparedness and
Response, 330 C St. SW, Washington,
DC 20201. Telephone: 202–205–7843;
Email: Natalie.grant@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: OHSEPR
announces the intent to award the
following single-source awards:
Recipient
United Way Worldwide, Alexandria, VA .........................
National Association of Social Workers, Washington,
DC .....................................
American Public Human
Services Association, Arlington, VA .........................
National Association of
County Human Services
Administrators, Washington, DC .........................
Award amount
of up to
$75,000
18:38 Sep 30, 2021
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Friday, June 25,
2021 (86 FR 33718), FR Doc. 2021–
13593, the following correction is made:
On page 33718, in the table, the entry
for ANDA 065152 is removed.
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21371 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
75,000
Elizabeth Leo,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
75,000
[FR Doc. 2021–21418 Filed 9–28–21; 4:15 pm]
BILLING CODE 8414–PC–P
75,000
United Way supports 211, which is
the most comprehensive source of
information about local resources and
services in the United States. United
Way’s 211 has demonstrated experience
providing disaster-related assistance to
disaster survivors. United Way’s
existing network of 211 agencies will
provide information and referrals to
evacuees from Afghanistan including
repatriates eligible for temporary
assistance.
NASW is the largest membership
organization of professional social
workers in the world. NASW has the
ability to train a large number of
professional social workers across the
United States, including many who
have provided case management and
human services following an
emergency. NASW will train its
members on how to provide culturally
competent case management and human
services to evacuees from Afghanistan
and ensure appropriate coordination
and subject matter expertise.
APHSA is a national membership
association representing state and local
health and human services agencies and
subject matter experts who help execute
their mission. APHSA has a direct
connection to a network of state and
county health and human services
executives with first-hand knowledge of
and expertise in operating programs and
delivering human services following an
emergency. APHSA will educate its
members on the provision of culturally
appropriate human services to evacuees
from Afghanistan by providing training
and technical assistance.
NACHSA members represent a broad
range of human services agencies
throughout the United States, including
VerDate Sep<11>2014
ones that provide public assistance,
child care, child protective services, and
adult protective services. NACHSA
supports the professional development
of county human services
administrators, whose agencies deliver
essential human services. NACHSA will
educate its membership on providing
culturally appropriate human services
to evacuees from Afghanistan and
ensure county level coordination of
services.
Statutory Authority: Social Security
Act, Title XI, Part A, Section 1113, 42
U.S. Code 1313(a)(3).
Jkt 256001
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0492]
Watson Laboratories, Inc., et al.;
Withdrawal of Approval of 36
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of June 25, 2021. The document
announced the withdrawal of approval
of 36 abbreviated new drug applications
(ANDAs) from multiple applicants as of
July 26, 2021. The document indicated
that FDA was withdrawing approval of
the following ANDA, after receiving a
withdrawal request from Yung Shin
Pharmaceutical Ind. Co. Ltd., authorized
U.S. agent, Carlsbad Technology, Inc./
Simon Law, 5922 Farnsworth Ct., Suite
101, Carlsbad, CA 92008: ANDA
065152, Cephalexin Capsules,
Equivalent to (EQ) 250 milligrams (mg)
base and EQ 500 mg base. Before FDA
withdrew the approval of this ANDA,
Yung Shin Pharmaceutical Ind. Co. Ltd.
informed FDA that it did not want the
approval of the ANDA withdrawn.
Because Yung Shin Pharmaceutical Ind.
Co. Ltd. timely requested that approval
of this ANDA not be withdrawn, the
approval of ANDA 065152 is still in
effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
PO 00000
Frm 00032
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
[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, Agency, or we) 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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
requests comments on the information
collection associated with FDA research
in obtaining information from
pharmacists and other management at
outsourcing facilities and related human
prescription drug compounding
businesses. The research supports a
comprehensive analysis of the
outsourcing facility sector that informs
ongoing FDA work in this area.
DATES: Submit either electronic or
written comments on the collection of
information by November 30, 2021.
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 November 30,
2021. The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
E:\FR\FM\01OCN1.SGM
01OCN1
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
comments until 11:59 p.m. Eastern Time
at the end of November 30, 2021.
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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
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
VerDate Sep<11>2014
18:04 Sep 30, 2021
Jkt 256001
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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. 3501–3521), 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
54451
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,
including each proposed extension of an
existing 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 0910–0883—
Extension
This information collection supports
FDA research in obtaining a range of
information pertaining to human
prescription drug compounding by
outsourcing facilities. Generally, drug
compounding is the practice of
combining, mixing, or altering
ingredients of a drug to create a
medication tailored an individual
patient’s needs. Although compounded
drugs can serve an important medical
need for certain patients when an
approved drug is not medically
appropriate, compounded drugs also
present a risk to patients. Compounded
drugs are not FDA-approved; therefore,
they do not undergo FDA premarket
review for safety, effectiveness, and
quality. Section 503A of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 353a) describes the
conditions that must be satisfied for
compounded human prescription drug
products to be exempt from certain
sections of the FD&C Act: (1) Section
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
E:\FR\FM\01OCN1.SGM
01OCN1
54452
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / Notices
(current good manufacturing practice
(CGMP) requirements), (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (labeling
of drugs with adequate directions for
use), and (3) section 505 (21 U.S.C. 355)
(approval of drugs under new drug
applications or abbreviated new drug
applications).
The Drug Quality and Security Act of
2013 (Pub. L. 113–54) created
outsourcing facilities—a new industry
sector of drug compounders held to
higher quality standards to protect
patient health. Section 503B of the
FD&C Act (21 U.S.C. 353b) describes the
conditions that outsourcing facilities
must satisfy for drug products
compounded in an outsourcing facility
by or under the direct supervision of a
licensed pharmacist to be exempt from
the certain sections of the FD&C Act.
Outsourcing facilities are intended to
offer a more reliable supply of
compounded drugs that hospitals,
clinics, and other providers need.
FDA continues to find concerning
quality and safety problems during
inspections of outsourcing facilities.
FDA has implemented and will
continue to implement programs to
support compounding quality and
compliance. One initiative is FDA’s
Compounding Quality Center of
Excellence (Center of Excellence),
https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence, which was
developed to focus on improving the
quality of compounded human
prescription drugs to promote patient
safety. One of our top priorities is to
help ensure that compounded drugs are
safe by focusing on quality. FDA, state
regulators, pharmacy associations, and
compounders, including outsourcing
facilities, share the responsibility of
patient safety.
The Center of Excellence engages and
collaborates with compounders,
including outsourcing facilities, and
other stakeholders to improve the
overall quality of compounded drugs.
Furthermore, the Center of Excellence
promotes collaboration to help
compounders implement robust quality
management systems that are better for
business and the safety of patients.
To help strengthen the outsourcing
facility industry’s ability to provide
quality compounded drugs to patients
who need them, the Center of
VerDate Sep<11>2014
18:04 Sep 30, 2021
Jkt 256001
Excellence offers training sessions and
opportunities to develop manufacturing
quality and other policies for
outsourcing facilities, including CGMPs.
The Center of Excellence offers
several training sessions (available at
https://www.fda.gov/drugs/humandrug-compounding/compoundingquality-center-excellence-trainingprograms). Self-guided training sessions
teach the following topics: (1)
Environmental monitoring, (2) sterile
drug compounding, (3) cleanroom
performance tests, and (4) conducting
investigations and formulating
corrective and preventive actions.
Instructor-led sessions teach the
regulatory framework for these topics:
(1) Human drug compounding, (2)
airflow practices, (3) insanitary
conditions and sterility, (4) stability and
beyond use dates, (5) requirements for
outsourcing facility guides, and (6)
conducting investigations and
formulating corrective and preventive
actions. Management and staff from
outsourcing facilities have attended the
training sessions. Feedback on the
training sessions has been positive, and
interest in the sessions continues to
grow.
In addition, the Center of Excellence
is conducting indepth research to better
understand outsourcing facilities’
challenges and opportunities in
different areas to help guide decisions
regarding future training and other
engagement. Outsourcing facilities
encounter the following challenges and
opportunities: (1) Operational barriers
and opportunities related to the
outsourcing facility market and business
viability, (2) knowledge and operational
barriers and opportunities related to
compliance with Federal policies and
good quality drug production, and (3)
barriers and opportunities related to
outsourcing facility interactions with
FDA.
FDA used previous research results
under this information collection to
develop an understanding of the
outsourcing facility sector, the sector’s
challenges, and opportunities for
advancement. The information collected
was an essential tool to help FDA
identify knowledge and information
gaps, operational barriers, and views on
interactions with FDA. FDA has
presented this information in public
settings such as stakeholder meetings.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Continuing this collection will enable
FDA to deepen our understanding of the
outsourcing facility sector and increase
our efficacy in developing a Center of
Excellence that is responsive to
outsourcing facilities’ needs. The
research results will inform FDA’s
future activities for the Center of
Excellence in the areas of
communication, education, training,
and other engagement with outsourcing
facilities to address challenges and
support advancement.
Researchers engage with pharmacists,
staff, and management from outsourcing
facilities and similar compounding
businesses and may use surveys,
interviews, and focus groups to obtain
information about outsourcing facilities’
challenges and opportunities. Within
this context, we may pose the following
questions or similar, related questions:
1. What financial and operational
considerations inform outsourcing
facility operational and business model
decisions?
2. What factors impact developing a
sustainable outsourcing facility
business?
3. What financial and operational
considerations inform outsourcing
facility product decisions?
4. Do outsourcing facilities
understand the Federal laws and
policies that apply to them? What, if
any, knowledge gaps do we need to
address?
5. What are outsourcing facilities’
challenges when implementing Federal
CGMP requirements?
6. How do outsourcing facilities
implement quality practices at their
facilities?
7. How do outsourcing facilities
develop CGMP and quality expertise?
How do they obtain this knowledge, and
what training do they need?
8. What are the economic
consequences of CGMP noncompliance
and 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?
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\01OCN1.SGM
01OCN1
54453
Federal Register / Vol. 86, No. 188 / Friday, October 1, 2021 / 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.
Our original request for the
information collection was approved
January 21, 2020; however, the
subsequent public health emergency
inhibited our ability to administer the
requested survey. We have therefore
made no adjustments to our current
burden estimate.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21382 Filed 9–30–21; 8:45 am]
BILLING CODE 4164–01–P
Electronic User Fee Payment Request
Forms—Form FDA 3913 and Form FDA
3914
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB Control Number 0910–0805—
Extension
Food and Drug Administration
[Docket No. FDA–2015–N–1837]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic User
Fee Payment Request Forms
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
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by November
1, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0805. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
VerDate Sep<11>2014
18:04 Sep 30, 2021
Jkt 256001
Form FDA 3913, User Fee Payment
Refund Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment refund. The information
collected includes the organization,
contact, and payment information. The
information is used to determine the
reason for the refund, the refund
amount, and who to contact if there are
any questions regarding the refund
request. A submission of the User Fee
Payment Refund Request form does not
guarantee that a refund will be issued.
FDA estimates an average of 0.40 hours
per response, including the time to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete and review the
collection of information. The estimated
hours are based on past FDA experience
with the user fee payment refund
request.
In fiscal year 2020, approximately 474
user fee refunds were processed for
cover sheets and invoices, including 0
for Animal Drug User Fees, 0 for Animal
Generic Drug User Fees, 1 for Biosimilar
Drug User Fees, 0 for Export Certificate
Program fees, 0 for Freedom of
Information Act requests, 31 for Generic
Drug User Fees, 200 for Medical Device
User Fees, 240 for Medical Device
Federal Unified Registration and Listing
fees, 0 for Mammography inspection
fees, 1 for Prescription Drug User Fees,
and 0 for Tobacco product fees.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum necessary information for
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with the
user fee payment transfer requests.
In fiscal year 2020, approximately 194
user fee payment transfers were
processed for cover sheets and invoices,
including 0 for Animal Drug User Fees,
0 for Animal Generic Drug User Fees, 1
for Biosimilar Drug User Fees, 34 for
Generic Drug User Fees, 78 for Medical
Device User Fees, 80 for Medical Device
Federal Unified Registration and Listing
fees, 0 for Mammography inspection
fees, 1 for Prescription Drug User Fees,
and 0 for Tobacco product fees.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
biological, medical device firms, etc.).
Specifically, refund request forms target
respondents who submitted a duplicate
payment or overpayment for a user fee
cover sheet or invoice. Respondents
may also include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms streamline the refund and
transfer processes, facilitate processing,
and improve the tracking of refund or
transfer requests. The burden for this
collection of information is the same for
all customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Respondents
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54450-54453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21382]
-----------------------------------------------------------------------
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, Agency, or we) 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice requests comments on the information collection
associated with FDA research in obtaining information from pharmacists
and other management at outsourcing facilities and related human
prescription drug compounding businesses. The research supports a
comprehensive analysis of the outsourcing facility sector that informs
ongoing FDA work in this area.
DATES: Submit either electronic or written comments on the collection
of information by November 30, 2021.
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 November 30, 2021. The https://www.regulations.gov electronic filing system will accept
[[Page 54451]]
comments until 11:59 p.m. Eastern Time at the end of November 30, 2021.
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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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. 3501-3521), 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, including
each proposed extension of an existing 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 0910-0883--Extension
This information collection supports FDA research in obtaining a
range of information pertaining to human prescription drug compounding
by outsourcing facilities. Generally, drug compounding is the practice
of combining, mixing, or altering ingredients of a drug to create a
medication tailored an individual patient's needs. Although compounded
drugs can serve an important medical need for certain patients when an
approved drug is not medically appropriate, compounded drugs also
present a risk to patients. Compounded drugs are not FDA-approved;
therefore, they do not undergo FDA premarket review for safety,
effectiveness, and quality. Section 503A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that
must be satisfied for compounded human prescription drug products to be
exempt from certain sections of the FD&C Act: (1) Section 501(a)(2)(B)
(21 U.S.C. 351(a)(2)(B))
[[Page 54452]]
(current good manufacturing practice (CGMP) requirements), (2) section
502(f)(1) (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate
directions for use), and (3) section 505 (21 U.S.C. 355) (approval of
drugs under new drug applications or abbreviated new drug
applications).
The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created
outsourcing facilities--a new industry sector of drug compounders held
to higher quality standards to protect patient health. Section 503B of
the FD&C Act (21 U.S.C. 353b) describes the conditions that outsourcing
facilities must satisfy for drug products compounded in an outsourcing
facility by or under the direct supervision of a licensed pharmacist to
be exempt from the certain sections of the FD&C Act. Outsourcing
facilities are intended to offer a more reliable supply of compounded
drugs that hospitals, clinics, and other providers need.
FDA continues to find concerning quality and safety problems during
inspections of outsourcing facilities. FDA has implemented and will
continue to implement programs to support compounding quality and
compliance. One initiative is FDA's Compounding Quality Center of
Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was
developed to focus on improving the quality of compounded human
prescription drugs to promote patient safety. One of our top priorities
is to help ensure that compounded drugs are safe by focusing on
quality. FDA, state regulators, pharmacy associations, and compounders,
including outsourcing facilities, share the responsibility of patient
safety.
The Center of Excellence engages and collaborates with compounders,
including outsourcing facilities, and other stakeholders to improve the
overall quality of compounded drugs. Furthermore, the Center of
Excellence promotes collaboration to help compounders implement robust
quality management systems that are better for business and the safety
of patients.
To help strengthen the outsourcing facility industry's ability to
provide quality compounded drugs to patients who need them, the Center
of Excellence offers training sessions and opportunities to develop
manufacturing quality and other policies for outsourcing facilities,
including CGMPs.
The Center of Excellence offers several training sessions
(available at https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence-training-programs). Self-guided
training sessions teach the following topics: (1) Environmental
monitoring, (2) sterile drug compounding, (3) cleanroom performance
tests, and (4) conducting investigations and formulating corrective and
preventive actions. Instructor-led sessions teach the regulatory
framework for these topics: (1) Human drug compounding, (2) airflow
practices, (3) insanitary conditions and sterility, (4) stability and
beyond use dates, (5) requirements for outsourcing facility guides, and
(6) conducting investigations and formulating corrective and preventive
actions. Management and staff from outsourcing facilities have attended
the training sessions. Feedback on the training sessions has been
positive, and interest in the sessions continues to grow.
In addition, the Center of Excellence is conducting indepth
research to better understand outsourcing facilities' challenges and
opportunities in different areas to help guide decisions regarding
future training and other engagement. Outsourcing facilities encounter
the following challenges and opportunities: (1) Operational barriers
and opportunities related to the outsourcing facility market and
business viability, (2) knowledge and operational barriers and
opportunities related to compliance with Federal policies and good
quality drug production, and (3) barriers and opportunities related to
outsourcing facility interactions with FDA.
FDA used previous research results under this information
collection to develop an understanding of the outsourcing facility
sector, the sector's challenges, and opportunities for advancement. The
information collected was an essential tool to help FDA identify
knowledge and information gaps, operational barriers, and views on
interactions with FDA. FDA has presented this information in public
settings such as stakeholder meetings. Continuing this collection will
enable FDA to deepen our understanding of the outsourcing facility
sector and increase our efficacy in developing a Center of Excellence
that is responsive to outsourcing facilities' needs. The research
results will inform FDA's future activities for the Center of
Excellence in the areas of communication, education, training, and
other engagement with outsourcing facilities to address challenges and
support advancement.
Researchers engage with pharmacists, staff, and management from
outsourcing facilities and similar compounding businesses and may use
surveys, interviews, and focus groups to obtain information about
outsourcing facilities' challenges and opportunities. Within this
context, we may pose the following questions or similar, related
questions:
1. What financial and operational considerations inform outsourcing
facility operational and business model decisions?
2. What factors impact developing a sustainable outsourcing
facility business?
3. What financial and operational considerations inform outsourcing
facility product decisions?
4. Do outsourcing facilities understand the Federal laws and
policies that apply to them? What, if any, knowledge gaps do we need to
address?
5. What are outsourcing facilities' challenges when implementing
Federal CGMP requirements?
6. How do outsourcing facilities implement quality practices at
their facilities?
7. How do outsourcing facilities develop CGMP and quality
expertise? How do they obtain this knowledge, and what training do they
need?
8. What are the economic consequences of CGMP noncompliance and
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?
FDA estimates the burden of this collection of information as
follows:
[[Page 54453]]
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.
Our original request for the information collection was approved
January 21, 2020; however, the subsequent public health emergency
inhibited our ability to administer the requested survey. We have
therefore made no adjustments to our current burden estimate.
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21382 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
