Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 28854-28856 [2018-13294]
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Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
under the user fee provisions of the
FD&C Act and the procedures for
submitting requests for waivers,
reductions, refunds, and requests for
reconsiderations or appeals. The revised
draft guidance also provides additional
clarification on certain issues such as
user fee exemptions for orphan drugs
and FDA’s current thinking on
considerations relevant to eligibility for
user fee waivers, reductions, and
refunds under the applicable statutory
provisions.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Prescription Drug User Fee Waivers,
Reductions, and Refunds for Drug and
Biological Products.’’ 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
draft guidance is not subject to
Executive Order 12866.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
(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.
The information collection of this
draft guidance has been submitted for
OMB renewal of approval under OMB
control number 0910–0693. In addition,
the collection of information associated
with Form FDA 3397 has been
previously approved under OMB
control number 0910–0297. Collection
of information associated with new drug
application or biologics license
applications have been previously
approved under OMB control numbers
0910–0001 and 0910–0338, respectively.
See section X of the draft guidance
document.
amozie on DSK3GDR082PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
VerDate Sep<11>2014
17:22 Jun 20, 2018
Jkt 244001
default.htm or https://
www.regulations.gov.
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13295 Filed 6–20–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2014–D–2138]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act
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,
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 adverse event
reporting for outsourcing facilities
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by August 20, 2018.
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 August 20,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 20, 2018.
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:
PO 00000
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• 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 2014–
D–2138 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry: Adverse Event Reporting
for 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
E:\FR\FM\21JNN1.SGM
21JNN1
Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/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
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:22 Jun 20, 2018
Jkt 244001
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.
Guidance for Industry: Adverse Event
Reporting for Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910–0800—
Extension
This information collection supports
Agency implementation of the Drug
Quality and Security Act (DQSA) (Pub.
L. 113–54), which amended the FD&C
Act by adding new section 503B (21
U.S.C. 353b).
This notice solicits comments on
adverse event reporting for outsourcing
facilities under section 503B of the
FD&C Act.
Under section 503B(b), a compounder
can register as an outsourcing facility
with FDA. If the conditions outlined in
section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or
under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from certain sections
of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
PO 00000
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Fmt 4703
Sfmt 4703
28855
approval of human drug products under
new drug applications (NDAs) or
abbreviated new drug applications
(ANDAs)). Drugs compounded in
outsourcing facilities are not exempt
from the requirements of section
501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs).
Under section 503B(b)(5), an
outsourcing facility must submit
adverse event reports to FDA in
accordance with the content and format
requirements established through
guidance or regulation under 21 CFR
310.305 (or any successor regulations).
Accordingly, we developed the
document, ‘‘Guidance for Industry:
Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act’’.1 The guidance explains
electronic reporting of adverse events in
accordance with § 310.305 with respect
to outsourcing facilities.
Under § 310.305(c)(1), manufacturers,
packers, and distributors of marketed
prescription drug products that are not
the subject of an approved NDA or
ANDA, including, as set forth in the
guidance, outsourcing facilities must
submit to FDA adverse event reports
within 15 calendar days of receiving the
information and must submit follow-up
reports within 15 calendar days of
receipt of new information about the
adverse event, or as requested by FDA.
Outsourcing facilities must submit the
adverse event report in an electronic
format that FDA can process, review,
and archive (collection of information is
approved by OMB control number
0910–0291). A copy of the current
labeling of the compounded drug
product must be provided.
Under § 310.305(g), entities subject to
the regulation must maintain for 10
years the records of all adverse events
required to be reported under § 310.305.
The outsourcing facility should also
maintain records of its efforts to obtain
the data elements described in the draft
guidance for each adverse event report.
We estimate the burden of the
information collection as follows:
1 Available at: https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM434188.pdf.
E:\FR\FM\21JNN1.SGM
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28856
Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Compounding outsourcing facility
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of adverse event reports including copy of labeling and other information as described in the guidance ..................................................................................
55
1
55
1.1
61
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Type of recordkeeping
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report
55
1
55
16
880
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the
information collection and we have
retained the currently approved burden
estimate. Based on our review of Agency
data, we estimate that annually 55
outsourcing facilities (‘‘Number of
Respondents’’ and ‘‘Total Annual
Responses’’ in table 1) will submit
adverse event reports to FDA as
specified in the guidance and that
preparing and submitting this
information will take approximately 1.1
hours per registrant (‘‘Average Burden
per Response’’ in table 1). Likewise, we
estimate that annually 55 outsourcing
facilities (‘‘Number of Recordkeepers’’
in table 2) will maintain records of
adverse events as specified in the
guidance and that preparing and
maintaining the records will take
approximately 16 hours per registrant
(‘‘Average Burden per Recordkeeping’’
in table 2).
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
longer marketed and requested that the
approval of the applications be
withdrawn.
[FR Doc. 2018–13294 Filed 6–20–18; 8:45 am]
DATES:
BILLING CODE 4164–01–P
Approval is withdrawn as of July
23, 2018.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2194]
Novartis Pharmaceuticals Corporation,
et al.; Withdrawal of Approval of Five
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five new drug
applications (NDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
SUMMARY:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 020831 ......
Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milligram (mg)/inhalation.
Axiron (testosterone) Transdermal Metered Solution, 30 mg/
1.5 milliliter (mL) actuation.
Rocephin (ceftriaxone sodium) for Injection, equivalent to
(EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM),
EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ
2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1%
(Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin
kit).
Rocephin (ceftriaxone sodium) with Dextrose in Plastic Container Injection, EQ 10 mg base/mL, EQ 20 mg base/mL,
and EQ 40 mg base/mL.
Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ......
Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 07936.
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
NDA 022504 ......
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NDA 050585 ......
NDA 050624 ......
NDA 202763 ......
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Do.
ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN
56623.
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]]>Agencies
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2014-D-2138]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: Adverse Event Reporting for
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 adverse event reporting for outsourcing facilities
under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by August 20, 2018.
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 August 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 20, 2018. 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 2014-D-2138 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry: Adverse
Event Reporting for 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
[[Page 28855]]
with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: 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.
Guidance for Industry: Adverse Event Reporting for Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910-0800--Extension
This information collection supports Agency implementation of the
Drug Quality and Security Act (DQSA) (Pub. L. 113-54), which amended
the FD&C Act by adding new section 503B (21 U.S.C. 353b).
This notice solicits comments on adverse event reporting for
outsourcing facilities under section 503B of the FD&C Act.
Under section 503B(b), a compounder can register as an outsourcing
facility with FDA. If the conditions outlined in section 503B(a) of the
FD&C Act are satisfied, a drug compounded by or under the direct
supervision of a licensed pharmacist in an outsourcing facility is
exempt from certain sections of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
adequate directions for use) and section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications (NDAs) or abbreviated new drug applications (ANDAs)).
Drugs compounded in outsourcing facilities are not exempt from the
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)) (concerning current good manufacturing practice for
drugs).
Under section 503B(b)(5), an outsourcing facility must submit
adverse event reports to FDA in accordance with the content and format
requirements established through guidance or regulation under 21 CFR
310.305 (or any successor regulations). Accordingly, we developed the
document, ``Guidance for Industry: Adverse Event Reporting for
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act''.\1\ The guidance explains electronic reporting of
adverse events in accordance with Sec. 310.305 with respect to
outsourcing facilities.
---------------------------------------------------------------------------
\1\ Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.
---------------------------------------------------------------------------
Under Sec. 310.305(c)(1), manufacturers, packers, and distributors
of marketed prescription drug products that are not the subject of an
approved NDA or ANDA, including, as set forth in the guidance,
outsourcing facilities must submit to FDA adverse event reports within
15 calendar days of receiving the information and must submit follow-up
reports within 15 calendar days of receipt of new information about the
adverse event, or as requested by FDA. Outsourcing facilities must
submit the adverse event report in an electronic format that FDA can
process, review, and archive (collection of information is approved by
OMB control number 0910-0291). A copy of the current labeling of the
compounded drug product must be provided.
Under Sec. 310.305(g), entities subject to the regulation must
maintain for 10 years the records of all adverse events required to be
reported under Sec. 310.305. The outsourcing facility should also
maintain records of its efforts to obtain the data elements described
in the draft guidance for each adverse event report.
We estimate the burden of the information collection as follows:
[[Page 28856]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Compounding outsourcing facility Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of adverse event reports including copy of labeling and 55 1 55 1.1 61
other information as described in the guidance....................
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Type of recordkeeping Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Records of adverse events, including records of efforts to obtain 55 1 55 16 880
the data elements for each adverse event report...................
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This is the first extension of the information collection and we
have retained the currently approved burden estimate. Based on our
review of Agency data, we estimate that annually 55 outsourcing
facilities (``Number of Respondents'' and ``Total Annual Responses'' in
table 1) will submit adverse event reports to FDA as specified in the
guidance and that preparing and submitting this information will take
approximately 1.1 hours per registrant (``Average Burden per Response''
in table 1). Likewise, we estimate that annually 55 outsourcing
facilities (``Number of Recordkeepers'' in table 2) will maintain
records of adverse events as specified in the guidance and that
preparing and maintaining the records will take approximately 16 hours
per registrant (``Average Burden per Recordkeeping'' in table 2).
Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13294 Filed 6-20-18; 8:45 am]
BILLING CODE 4164-01-P
