Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability, 8872-8874 [2015-03419]
Download as PDF
<![CDATA[
8872
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
Drug, and Cosmetic Act (the FD&C Act),
as added by the Drug Quality and
Security Act (DQSA), of the regulatory
implications of registration as an
outsourcing facility.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 20, 2015.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Guidance for Entities Considering
Whether to Register as Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
On November 27, 2013, President
Obama signed the DQSA (Pub. L. 113–
54) into law. The DQSA added a new
section 503B to the FD&C Act that
created a category of entities called
‘‘outsourcing facilities.’’ Section
503B(d)(4) of the FD&C Act (21 U.S.C.
353b(d)(4)) defines an outsourcing
facility, in part, as a facility that
complies with all of the requirements of
section 503B, including registering with
FDA as an outsourcing facility and
paying associated fees. 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
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
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).
FDA has received questions about
whether entities engaged in various
types of activities (e.g., a facility that is
compounding only non-sterile drugs or
only repackaging biological products)
should register as an outsourcing
facility. Because entities that register as
outsourcing facilities in fiscal year 2015
(beginning October 1, 2014) must pay a
registration fee and FDA has determined
that fees paid pursuant to sections 503B
and 744K of the FD&C Act will not be
refunded, FDA is issuing this guidance
to answer some of these questions and
to provide potential registrants
additional information about the
regulatory impact of registering as an
outsourcing facility.
Elsewhere in this volume of the
Federal Register, FDA is announcing
the availability of separate FDA
guidance documents on (1) mixing,
diluting, or repackaging biological
products outside the scope of an
approved biologics license application,
and (2) repackaging certain human drug
products by pharmacies and
outsourcing facilities. These guidance
documents describe FDA’s compliance
policies with respect to biological
products that are mixed, diluted, or
repackaged outside the scope of an
approved biologics license application
and repackaged human drugs.
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 Agency’s current thinking
on registering as an outsourcing facility
under section 503B of the FD&C Act. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03416 Filed 2–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2138]
Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Adverse
Event Reporting for Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), an
outsourcing facility must submit
adverse event reports to FDA. This
guidance explains FDA’s current
thinking on adverse event reporting for
outsourcing facilities.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work to
finalize the guidance, submit either
electronic or written comments on this
draft guidance by May 20, 2015. Submit
either electronic or written comments
concerning the collection of information
proposed in the draft guidance by May
20, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
SUMMARY:
E:\FR\FM\19FEN1.SGM
19FEN1
8873
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
4th Floor, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: H.
Joy Sharp, Office of Compliance, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.’’ On November 27, 2013,
President Obama signed the Drug
Quality and Security Act (DQSA) into
law (Pub. L. 113–54). The DQSA added
a new section 503B to the FD&C Act (21
U.S.C. 353b). Under section 503B(b), a
compounder can register as an
outsourcing facility with FDA. Section
503B(d)(4) of the FD&C Act defines an
outsourcing facility, in part, as a facility
that complies with all of the
requirements of section 503B, including
registering with FDA as an outsourcing
facility and paying associated fees. 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 section
310.305 of title 21, Code of Federal
Regulations (or any successor
regulations). This draft guidance
explains how FDA intends to
implement § 310.305 with respect to
outsourcing facilities.
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 Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (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 that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this
document, FDA invites comments on
the following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the draft guidance, registered
outsourcing facilities must submit to
FDA adverse event reports within 15
calendar days of receiving the
information and must submit a followup
report 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 using the existing
Form FDA 3500A (which is approved by
OMB control number 0910–0291) or an
alternate method in accordance with
§ 310.305(d). A copy of the current
labeling of the compounded drug
product must be included. Each form
should be submitted with a cover letter
that includes the following heading:
‘‘Adverse event report submitted by
human drug compounding outsourcing
facility (503B).’’
Under § 310.305, entities subject to
the regulation must maintain for 10
years the records of all adverse events
required to be reported under § 310.305,
including raw data and any
correspondence relating to the adverse
event. 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.
The total estimated reporting and
recordkeeping burdens for the draft
guidance are as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
emcdonald on DSK67QTVN1PROD with NOTICES
Type of reporting
Number of
responses per
respondent
Total annual
responses
Average burden per response
(hours)
Total hours
Submission of adverse event reports including cover letter,
copy of labeling, and other information as described in
the draft guidance ............................................................
50
2
100
1.1
110
Total ..............................................................................
........................
........................
........................
........................
110
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\19FEN1.SGM
19FEN1
8874
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
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
(hours)
Total hours
Records of adverse events, including records of efforts to
obtain the data elements for each adverse event report
50
1
50
16
800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments can be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03419 Filed 2–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1459]
Memorandum of Understanding
Addressing Certain Distributions of
Compounded Human Drug Products
Between the States and the Food and
Drug Administration; New Proposed
Draft; Availability
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
withdrawal.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability for public
comment of a draft standard
memorandum of understanding (MOU)
entitled ‘‘Memorandum of
Understanding Addressing Certain
Distributions of Compounded Human
Drug Products Between the State of
SUMMARY:
VerDate Sep<11>2014
16:58 Feb 18, 2015
Jkt 235001
[insert State] and the U.S. Food and
Drug Administration.’’ The draft
standard MOU describes the
responsibilities of the State that chooses
to sign the MOU in investigating and
responding to complaints related to
compounded human drug products
distributed outside the State and in
addressing the interstate distribution of
inordinate amounts of compounded
human drug products.
FDA is also announcing the
withdrawal of an earlier draft standard
MOU entitled ‘‘Memorandum of
Understanding on Interstate Distribution
of Compounded Drug Products,’’ which
was issued in January 1999. The January
1999 draft standard MOU is superseded
by the new draft standard MOU.
DATES: FDA is withdrawing its draft
standard MOU that published on
January 21, 1999 (64 FR 3301), as of
February 19, 2015. Submit either
electronic or written comments on the
new draft standard MOU by June 19,
2015. Submit comments on information
collection issues under the Paperwork
Reduction Act of 1995 by June 19, 2015
(see the ‘‘Paperwork Reduction Act of
1995’’ section of this document).
ADDRESSES: Submit written requests for
single copies of the MOU to Edisa
Gozun, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Suite 5100, Silver
Spring, MD 20993–0002. Send one selfaddressed label to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the new draft
standard MOU.
Submit electronic comments on the
new draft standard MOU or on the
collection of information to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Edisa Gozun, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Suite 5100, Silver
Spring, MD 20993–0002, 301–796–3110.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
I. Background
Section 503A of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 353a) describes the
conditions that must be satisfied for
drug products compounded by a
licensed pharmacist or licensed
physician to be exempt from the
following sections of the FD&C Act: (1)
Section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice (CGMP)
requirements), (2) section 502(f)(1) (21
U.S.C. 352(f)(1)) (concerning the
labeling of drugs with adequate
directions for use), and (3) section 505
(21 U.S.C. 355) (concerning the approval
of drugs under new drug applications or
abbreviated new drug applications).
One of the conditions to qualify for
the exemptions listed in section 503A of
the FD&C Act is that (1) the drug
product is compounded in a State that
has entered into an MOU with FDA that
addresses the distribution of inordinate
amounts of compounded drug products
interstate and provides for appropriate
investigation by a State agency of
complaints relating to compounded
drug products distributed outside such
State; or (2) if the drug product is
compounded in a State that has not
entered into such an MOU, the licensed
pharmacist, pharmacy, or physician
does not distribute, or cause to be
distributed, compounded drug products
out of the State in which they are
compounded in quantities that exceed 5
percent of the total prescription orders
dispensed or distributed by such
pharmacy or physician (see section
503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the
FD&C Act).
Section 503A(b)(3)(B) of the FD&C Act
directs FDA to develop, in consultation
with the National Association of Boards
of Pharmacy (NABP), a standard MOU
for use by the States in complying with
section 503A(b)(3)(B)(i).
II. Previous Efforts To Develop a
Standard MOU
In the Federal Register of January 21,
1999 (64 FR 3301), FDA announced the
availability for public comment of a
draft standard MOU, developed in
consultation with NABP (1999 draft
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8872-8874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03419]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2138]
Adverse Event Reporting for Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must
submit adverse event reports to FDA. This guidance explains FDA's
current thinking on adverse event reporting for outsourcing facilities.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work to finalize the guidance, submit
either electronic or written comments on this draft guidance by May 20,
2015. Submit either electronic or written comments concerning the
collection of information proposed in the draft guidance by May 20,
2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
[[Page 8873]]
4th Floor, Silver Spring, MD 20993. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: H. Joy Sharp, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' On November
27, 2013, President Obama signed the Drug Quality and Security Act
(DQSA) into law (Pub. L. 113-54). The DQSA added a new section 503B to
the FD&C Act (21 U.S.C. 353b). Under section 503B(b), a compounder can
register as an outsourcing facility with FDA. Section 503B(d)(4) of the
FD&C Act defines an outsourcing facility, in part, as a facility that
complies with all of the requirements of section 503B, including
registering with FDA as an outsourcing facility and paying associated
fees. 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 section
310.305 of title 21, Code of Federal Regulations (or any successor
regulations). This draft guidance explains how FDA intends to implement
Sec. 310.305 with respect to outsourcing facilities.
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 Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Under the draft guidance, registered outsourcing facilities must
submit to FDA adverse event reports within 15 calendar days of
receiving the information and must submit a followup report 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 using the existing Form FDA 3500A (which is approved by
OMB control number 0910-0291) or an alternate method in accordance with
Sec. 310.305(d). A copy of the current labeling of the compounded drug
product must be included. Each form should be submitted with a cover
letter that includes the following heading: ``Adverse event report
submitted by human drug compounding outsourcing facility (503B).''
Under Sec. 310.305, entities subject to the regulation must
maintain for 10 years the records of all adverse events required to be
reported under Sec. 310.305, including raw data and any correspondence
relating to the adverse event. 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.
The total estimated reporting and recordkeeping burdens for the
draft guidance are as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of reporting Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Submission of adverse event 50 2 100 1.1 110
reports including cover letter,
copy of labeling, and other
information as described in the
draft guidance.................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 110
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 8874]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Type of recordkeeping recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of adverse events, including records of efforts to obtain 50 1 50 16 800
the data elements for each adverse event report...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
can be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03419 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P
