Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 34184-34186 [2019-15124]
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34184
Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
prevention strategies across the life
course; (5) monitors and evaluates the
outcomes of division investments in
states, territories, and local jurisdictions
using rigorous evaluation methods and
widely disseminates findings to
improve programmatic activities; (6)
publishes the findings of programmatic
evaluations in the peer-reviewed
literature and other reports and
participate in scientific and professional
conferences; (7) serves as a resource,
collaborates, and provides
comprehensive technical assistance and
training to states, territories, local
jurisdictions and other partners to
reduce drug use and overdose; (8)
synthesizes relevant research,
evaluation findings, evidence, and
trends to develop practical guidance
and resources that enhance overdose
prevention programs, strategies, and
activities; (9) uses research findings to
develop new strategies, policies, and
interventions or to improve the impact
of existing strategies, policies, and
interventions to prevent and reduce
overdose, its risk factors, and its
consequences; (10) collaborates with
state, territorial, and local jurisdictions,
public safety/law enforcement, and
other partners to use data to drive
decision-making and action, and; (11)
provides direct support to states,
territories, and local jurisdictions to
prevent drug use and overdose.
IV. Delegations of Authority: All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
(Authority: 44 U.S.C. 3101)
Alex M. Azar II,
Secretary.
[FR Doc. 2019–15169 Filed 7–16–19; 8:45 am]
BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSK3GLQ082PROD with NOTICES
[Docket No. FDA–2013–N–1428]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
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,
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
solicits comments on electronic drug
product reporting for human drug
compounding outsourcing facilities
under section 503B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by September 16, 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 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 16, 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
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
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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–
2013–N–1428 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry on Electronic Drug Product
Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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,
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
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Electronic Drug Product Reporting for
Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act
OMB Control Number 0910–0827—
Extension
The Drug Quality and Security Act
added section 503B to the FD&C Act (21
U.S.C. 353b) creating a category of
entities called ‘‘outsourcing facilities.’’
Outsourcing facilities, as defined in
section 503B(d)(4) of the FD&C Act, are
facilities that must meet all the
requirements described in section 503B,
including registering with FDA as an
outsourcing facility and submitting
regular reports identifying the drugs
compounded by the outsourcing facility
during the previous six-month period.
The first of these reports must be
submitted upon initial registration as an
outsourcing facility. Thereafter,
semiannual product reports must be
submitted, once during the month of
June and once during the month of
December, for as long as an
establishment remains registered as an
outsourcing facility.
In addition, drug products
compounded in an outsourcing facility
can qualify for exemptions from the
FDA approval requirements in section
505 of the FD&C Act (21 U.S.C. 355) and
the requirement to label products with
adequate directions for use under
section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)) if the requirements in
section 503B are met.
To help respondents understand the
statutory requirements, how we
interpret them, and the associated
information collection, we developed
the guidance document entitled,
‘‘Guidance for Industry; Electronic Drug
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ The
guidance explains that, once an entity
has elected to register as an outsourcing
facility, it must submit reports
identifying the drugs compounded by
the outsourcing facility. The guidance
also communicates who must report, the
format of the report, the content to
include in each report, when to report,
how reports are submitted to FDA, and
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34185
the consequences of outsourcing
facilities’ failure to submit reports.
Based on current data for outsourcing
facilities, we estimate that 75
outsourcing facilities will submit an
initial report identifying all drugs
compounded in the facility in the
previous six months. For the purposes
of this estimate, each product’s
structured product labeling (SPL)
submission is considered a separate
response, and therefore each facility’s
product report will include multiple
responses. Taking into account that a
particular product that is compounded
into different strengths from different
sources of active ingredient can be
reported in a single SPL response, we
estimate that each facility will average
76 products. Our estimate is based on
current product reporting data.
We expect each product report will
consist of multiple SPL responses per
facility and estimate that preparing and
submitting this information
electronically may take up to 2 hours for
each initial SPL response. We also
estimate that the 75 registered
outsourcing facilities will submit a
report twice each year identifying all
drugs compounded at the facility in the
previous six months.
As stated above, we estimate on
average 76 SPL responses per facility
and that preparing and submitting this
information electronically will take
approximately 30 minutes per response.
We have reduced our burden estimate
for semiannual product submissions
since outsourcing facilities can save
each SPL response once initially created
and submitted. For subsequent reports,
an outsourcing facility may resubmit the
same file(s) after changing the RootID
and version number (both SPL
metadata), effective date (to identify the
reporting period), and the number of
units produced, along with other data as
appropriate, to appropriate values for
the reporting period. Furthermore, if a
product was not compounded during a
particular reporting period, no SPL
response needs be sent for that product
during that reporting period.
We expect to receive no more than
one waiver request, each, from the
electronic submission process for initial
product reports and semiannual reports,
and that each waiver request will take
1 hour to prepare and submit.
We therefore estimate the burden of
the information collection as follows:
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Federal Register / Vol. 84, No. 137 / Wednesday, July 17, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Initial product reports ...........................................................
Waiver request from electronic submission of initial product reports ........................................................................
June product reports ............................................................
December product reports ...................................................
Waiver request from electronic submission of product reports ..................................................................................
75
1.01
76
2
152
1
75
75
1
1.01
1.01
1
76
76
1
.5
.5
1
38
38
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
230
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on submissions we have
received, we have reduced the number
of responses significantly since our
original estimate establishing the
collection. This results in an overall
reduction to the information collection
by 36,072 hours.
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15124 Filed 7–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–3586]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups
About Drug Products as Used by the
Food and Drug Administration
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
solicits comments on the information
collection resulting from focus groups
about drug products as used by FDA.
DATES: Submit either electronic or
written comments on the collection of
information by September 16, 2019.
SUMMARY:
VerDate Sep<11>2014
18:05 Jul 16, 2019
Jkt 247001
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 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 16, 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.
ADDRESSES:
Electronic Submissions
Food and Drug Administration
jbell on DSK3GLQ082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Product reporting for compounding outsourcing facilities
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:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
• 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–
2016–N–3586 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Focus
Groups About Drug Products as Used by
the Food and Drug Administration.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34184-34186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15124]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
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, 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 solicits comments on electronic drug product reporting for human
drug compounding outsourcing facilities under section 503B of the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by September 16, 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 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 16, 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-2013-N-1428 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry on
Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80
[[Page 34185]]
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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, 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.
Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act
OMB Control Number 0910-0827--Extension
The Drug Quality and Security Act added section 503B to the FD&C
Act (21 U.S.C. 353b) creating a category of entities called
``outsourcing facilities.'' Outsourcing facilities, as defined in
section 503B(d)(4) of the FD&C Act, are facilities that must meet all
the requirements described in section 503B, including registering with
FDA as an outsourcing facility and submitting regular reports
identifying the drugs compounded by the outsourcing facility during the
previous six-month period. The first of these reports must be submitted
upon initial registration as an outsourcing facility. Thereafter,
semiannual product reports must be submitted, once during the month of
June and once during the month of December, for as long as an
establishment remains registered as an outsourcing facility.
In addition, drug products compounded in an outsourcing facility
can qualify for exemptions from the FDA approval requirements in
section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to
label products with adequate directions for use under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section
503B are met.
To help respondents understand the statutory requirements, how we
interpret them, and the associated information collection, we developed
the guidance document entitled, ``Guidance for Industry; Electronic
Drug Product Reporting for Human Drug Compounding Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' The guidance explains that, once an entity has elected to
register as an outsourcing facility, it must submit reports identifying
the drugs compounded by the outsourcing facility. The guidance also
communicates who must report, the format of the report, the content to
include in each report, when to report, how reports are submitted to
FDA, and the consequences of outsourcing facilities' failure to submit
reports.
Based on current data for outsourcing facilities, we estimate that
75 outsourcing facilities will submit an initial report identifying all
drugs compounded in the facility in the previous six months. For the
purposes of this estimate, each product's structured product labeling
(SPL) submission is considered a separate response, and therefore each
facility's product report will include multiple responses. Taking into
account that a particular product that is compounded into different
strengths from different sources of active ingredient can be reported
in a single SPL response, we estimate that each facility will average
76 products. Our estimate is based on current product reporting data.
We expect each product report will consist of multiple SPL
responses per facility and estimate that preparing and submitting this
information electronically may take up to 2 hours for each initial SPL
response. We also estimate that the 75 registered outsourcing
facilities will submit a report twice each year identifying all drugs
compounded at the facility in the previous six months.
As stated above, we estimate on average 76 SPL responses per
facility and that preparing and submitting this information
electronically will take approximately 30 minutes per response. We have
reduced our burden estimate for semiannual product submissions since
outsourcing facilities can save each SPL response once initially
created and submitted. For subsequent reports, an outsourcing facility
may resubmit the same file(s) after changing the RootID and version
number (both SPL metadata), effective date (to identify the reporting
period), and the number of units produced, along with other data as
appropriate, to appropriate values for the reporting period.
Furthermore, if a product was not compounded during a particular
reporting period, no SPL response needs be sent for that product during
that reporting period.
We expect to receive no more than one waiver request, each, from
the electronic submission process for initial product reports and
semiannual reports, and that each waiver request will take 1 hour to
prepare and submit.
We therefore estimate the burden of the information collection as
follows:
[[Page 34186]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of
compounding outsourcing Number of responses per Total annual Average burden Total hours
facilities respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Initial product reports......... 75 1.01 76 2 152
Waiver request from electronic 1 1 1 1 1
submission of initial product
reports........................
June product reports............ 75 1.01 76 .5 38
December product reports........ 75 1.01 76 .5 38
Waiver request from electronic 1 1 1 1 1
submission of product reports..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 230
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on submissions we have received, we have reduced the number
of responses significantly since our original estimate establishing the
collection. This results in an overall reduction to the information
collection by 36,072 hours.
Dated: July 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15124 Filed 7-16-19; 8:45 am]
BILLING CODE 4164-01-P
