Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability, 1170-1173 [2011-94]
Download as PDF
<![CDATA[
1170
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February 7,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0553. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
301–796–5156, e-mail:
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Devices: Recommended
Glossary and Educational Outreach to
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use—
(OMB Control Number 0910–0553)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device so that it is
not misbranded. Section 351 of the
Public Health Service Act (the PHS Act)
(42 U.S.C. 262) establishes requirements
that manufacturers of biological
products must submit a license
application for FDA review and
approval prior to marketing a biological
product for introduction into interstate
commerce.
In the Federal Register of November
30, 2004 (69 FR 69606), FDA published
a notice of availability of the guidance
entitled ‘‘Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use.’’
The guidance document provides
guidance for the voluntary use of
selected symbols in place of text in
labeling. It provides the labeling
guidance required for: (1) In vitro
diagnostic devices (IVDs), intended for
professional use under 21 CFR 809.10,
FDA’s labeling requirements for IVDs;
and (2) FDA’s labeling requirements for
biologics, including IVDs under 21 CFR
parts 610 and 660. Under section 502(c)
of the FD&C Act, a drug or device is
misbranded, ‘‘* * *If any word,
statement, or other information required
by or under authority of this Act to
appear on the label or labeling is not
prominently placed thereon with such
conspicuousness (as compared with
other words, statements, designs, or
devices, in the labeling) and in such
terms as to render it likely to be read
and understood by the ordinary
individual under customary conditions
of purchase and use.’’
The guidance document recommends
that a glossary of terms accompany each
IVD to define the symbols used on that
device’s labels and/or labeling.
Furthermore, the guidance recommends
an educational outreach effort to
enhance the understanding of newly
introduced symbols. Both the glossary
and educational outreach information
will help to ensure that IVD users will
have enough general familiarity with the
symbols used, as well as provide a quick
reference for available materials, thereby
further ensuring that such labeling
satisfies the labeling requirements under
section 502(c) of the FD&C Act and
section 351 of the PHS Act.
The likely respondents for this
collection of information are IVD
manufacturers who plan to use the
selected symbols in place of text on the
labels and/or labeling of their IVDs.
The glossary activity is inclusive of
both domestic and foreign IVD
manufacturers. FDA receives
submissions from approximately 689
IVD manufacturers annually. The
number of hours per response for the
glossary and educational outreach
activities were derived from
consultation with a trade association
and FDA personnel. The 4-hour
estimate for a glossary is based on the
average time necessary for a
manufacturer to modify the glossary for
the specific symbols used in labels or
labeling for the IVDs manufactured.
In the Federal Register of October 5,
2010 (75 FR 61494), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Section 502 of the FD&C Act/Section 351 of the PHS Act
Glossary ...............................................................................
1 There
689
Total annual
responses
1
689
Hours per
response
Total hours
4
2,756
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–74 Filed 1–6–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0610]
BILLING CODE 4160–01–P
jdjones on DSK8KYBLC1PROD with NOTICES
Annual
frequency per
response
Draft Guidance for Industry on
Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
PO 00000
Notice.
Frm 00043
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Postmarketing
Adverse Event Reporting for Medical
Products and Dietary Supplements
During an Influenza Pandemic.’’ The
draft guidance discusses FDA’s
intended approach to enforcement of
adverse event reporting requirements for
drugs, biologics, medical devices, and
dietary supplements during an
influenza pandemic. The agency makes
recommendations to industry for
focusing limited resources on reports
SUMMARY:
E:\FR\FM\07JAN1.SGM
07JAN1
jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
related to products indicated for the
prevention and treatment of influenza
and other specific types of reports
indicated in the draft guidance. This
draft guidance is a revision of the draft
guidance for industry of the same title
published on December 16, 2008.
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
written or electronic comments on the
draft guidance by March 8, 2011.
Submit written comments on the
proposed collection of information by
March 8, 2011.
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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. 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:
Regarding pandemic influenza:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4146, Silver Spring, MD 20993–0002,
301–796–8510.
Regarding human drug products:
Solomon Iyasu, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4447,
Silver Spring, MD 20993–0002, 301–
796–2370.
Regarding human biological products:
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–6210.
Regarding medical device products:
Deborah Moore, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3230, Silver Spring,
MD 20993–0002, 301–796–6106.
Regarding dietary supplements: John
Sheehan, Center for Food Safety and
Applied Nutrition (HFS–315), Food and
Drug Administration, 5100 Paint Branch
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
Pkwy., College Park, MD 20740, 301–
436–1488.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic.’’ In the Federal
Register of December 16, 2008 (73 FR
76364), FDA published notice of the
availability of a draft guidance of the
same title. FDA anticipates that during
an influenza pandemic, industry and
FDA workforces may be reduced while
reporting of adverse events related to
widespread use of medical products
indicated for the treatment and
prevention of influenza may increase,
although the extent of these possible
changes is unknown. The revised draft
guidance discusses FDA’s intended
approach to enforcement of adverse
event reporting requirements for drugs,
biologics, medical devices, and dietary
supplements during an influenza
pandemic.
II. Revisions to the 2008 Draft Guidance
FDA is issuing a revised draft
guidance that includes
recommendations for planning,
notification, and documentation for
firms that report postmarketing adverse
events. The revised draft guidance
recommends that each firm’s pandemic
influenza continuity of operations plan
(COOP) include instructions for
reporting adverse events and a plan for
the submission of stored reports that
were not submitted within regulatory
timeframes. The revised draft guidance
recommends that firms that are unable
to fulfill normal adverse event reporting
requirements during an influenza
pandemic do the following:
• Document the conditions that
prevent them from meeting normal
reporting requirements,
• Notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when these conditions exist and when
the reporting process is restored, and
• Maintain records to identify what
reports have been stored.
These recommendations represent
collections of information under the
Paperwork Reduction Act of 1995 (the
PRA) (44 U.S.C. 3501–3520) discussed
in section IV of this document. In
issuing this revised draft guidance, FDA
considered all comments that were
submitted in response to the December
2008 draft guidance. Most comments
requested that greater clarity be
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
1171
provided in certain sections; FDA has
revised these sections accordingly.
This draft guidance does not address
monitoring and reporting of adverse
events that might be imposed as a
condition of authorization for products
authorized for emergency use under
section 564 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360bbb–3). This draft guidance
also does not address monitoring and
reporting of adverse events as required
by regulations establishing the
conditions for investigational use of
drugs, biologics, and devices. (See 21
CFR parts 312 and 812.)
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 postmarketing adverse event
reporting for medical products and
dietary supplements during pandemic
influenza. 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.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Paperwork Reduction Act of 1995
Under the PRA, 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 this
notice of the proposed collection of
information set forth in this document.
E:\FR\FM\07JAN1.SGM
07JAN1
1172
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
With respect to the collection of
information associated with this draft
guidance, 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.
The draft guidance explains FDA’s
approach to enforcement of adverse
event reporting requirements for drugs,
biologics, medical devices, and dietary
supplements during an influenza
pandemic, including an intent not to
object to changes in the timing of
submission of certain reports during
some stages of the pandemic response.
The Agency recommends that each
firm’s pandemic influenza COOP
include instructions for reporting
adverse events, including a plan for the
submission of stored reports that were
not submitted within regulatory
timeframes. The draft guidance explains
that firms that are unable to fulfill
normal adverse event reporting
requirements during an influenza
pandemic should: (1) Maintain
documentation of the conditions that
prevent them from meeting normal
reporting requirements, (2) notify the
appropriate FDA organizational unit
responsible for adverse event reporting
compliance when the conditions exist
and when the reporting process is
restored, and (3) maintain records to
identify what reports have been stored.
Based on the number of
manufacturers that would be covered by
the draft guidance, we estimate that
approximately 5,000 firms will add to
their COOP: (1) Instructions for
reporting adverse events and (2) a plan
for submitting stored reports that were
not submitted within regulatory
timeframes. We estimate that each firm
will take approximately 50 hours to
prepare the adverse event reporting plan
for its COOP.
We estimate that approximately 500
firms will be unable to fulfill normal
adverse event reporting requirements
because of conditions caused by an
influenza pandemic and that these firms
will notify the appropriate FDA
organizational unit responsible for
adverse event reporting compliance
when the conditions exist. Although we
do not anticipate such pandemic
influenza conditions to occur every
year, for purposes of the PRA, we
estimate that each of these firms will
notify FDA approximately once each
year, and that each notification will take
approximately 8 hours to prepare and
submit.
Concerning the recommendation in
the draft guidance that firms unable to
fulfill normal adverse event reporting
requirements maintain documentation
of the conditions that prevent them from
meeting these requirements and also
maintain records to identify what
adverse event reports have been stored
and when the reporting process is
restored, we estimate that
approximately 500 firms will each need
approximately 8 hours to maintain the
documentation and that approximately
500 firms will each need approximately
8 hours to maintain the records.
Therefore, the total recordkeeping
burden that would result from the draft
guidance would be 258,000 hours.
The draft guidance also refers to
previously approved collections of
information found in FDA’s adverse
event reporting requirements in 21 CFR
310.305, 314.80, 314.98, 600.80,
606.170, 640.73, 1271.350, and part 803.
These regulations contain collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520) and
are approved under OMB control
numbers 0910–0116, 0910–0291, 0910–
0230, 0910–0308, 0910–0437, and 0910–
0543. In addition, the draft guidance
also refers to adverse event reports for
nonprescription human drug products
marketed without an approved
application and dietary supplements
required under sections 760 and 761 of
the FD&C Act (21 U.S.C. 379aa and
379aa–1), which include collections of
information approved under OMB
control numbers 0910–0636 and 0910–
0635.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total
responses
Hours per
response
Total hours
Notify FDA when normal reporting is not feasible ...............
500
1
500
8
4,000
Total ..............................................................................
........................
........................
........................
........................
4,000
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
jdjones on DSK8KYBLC1PROD with NOTICES
Number of
recordkeepers
Number of
records per
recordkeeping
Add adverse event reporting plan to COOP .......................
Maintain documentation of influenza pandemic conditions
and resultant high absenteeism .......................................
Maintain records to identify what reports have been stored
and when the reporting process was restored ................
5,000
1
5,000
50
250,000
500
1
500
8
4,000
500
1
500
8
4,000
Total ..............................................................................
........................
........................
........................
........................
258,000
1 There
Total records
are no capital costs or operating and maintenance costs associated with this information collection.
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\07JAN1.SGM
07JAN1
Hours per
record
Total hours
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 4173, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist the
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 on the draft guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Leonard Sacks, Office of Critical Path
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 32, rm. 4174, Silver Spring,
MD 20993–0002, 301–796–8502.
SUPPLEMENTARY INFORMATION:
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/Food/Guidance
ComplianceRegulatoryInformation/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–94 Filed 1–6–11; 8:45 am]
BILLING CODE 4110–01–P
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0643]
Draft Guidance for Industry on
Electronic Source Documentation in
Clinical Investigations; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Electronic Source
Documentation in Clinical
Investigations.’’ This document provides
guidance to sponsors, contract research
organizations (CROs), data management
centers, and clinical investigators on
capturing, using, and archiving
electronic data in FDA-regulated
clinical investigations. It also describes
FDA’s recommended procedures for
ensuring the reliability, quality,
integrity, and traceability of electronic
source data and source records
maintained at the site for FDA
inspection.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that FDA
considers your comments on the draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by April 7, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Critical Path Programs, Office
jdjones on DSK8KYBLC1PROD with NOTICES
DATES:
VerDate Mar<15>2010
15:30 Jan 06, 2011
Jkt 223001
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Electronic Source Documentation in
Clinical Investigations.’’ This guidance
is intended to be used together with the
guidances for industry 1 entitled:
• Computerized Systems Used in
Clinical Investigations,
• Part 11, Electronic Records;
Electronic Signatures—Scope and
Application, and
• General Principles of Software
Validation; Final Guidance for Industry
and FDA Staff.
With the increasing use of
computerized systems in clinical
investigations, it is common to find
source data documented in an electronic
format, e.g., clinical data initially
documented in electronic health records
maintained by hospitals and
institutions, electronic case report
forms, laboratory reports that are
electronically generated, electronic
medical images from devices, and
electronic diaries provided by study
subjects. When paper source documents
are available for review, tracing of data
in paper-based studies can be performed
easily. However, when source data is
electronic, the data is traced through
complex data capture, transmission, and
archival processes. This guidance
recommends practices that will help
ensure that electronic source data and
source records are accurate, legible,
1 FDA guidances are available on FDA’s Web page
at https://www.fda.gov/RegulatoryInformation/
Guidances/default.htm. FDA guidances are issued
and updated regularly. We recommend you check
the Web site to ensure that you have the most upto-date version of a guidance.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
1173
original, attributable (e.g., user name
and password), and contemporaneously
entered; and meet the regulatory
requirements for recordkeeping and
retention.
The following specific topics related
to electronic source data are discussed:
• The identification of the data
element as the basic unit of information
in the electronic case report form;
• The description of a source of each
data element;
• Information about the electronic
creation, modification, transmission,
and storage of source data and
documents;
• Investigator responsibilities with
respect to reviewing and archiving
electronic data;
• Transmission of the data to the
sponsor and/or other designated parties;
and
• Preservation of data integrity.
The 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 capturing, using, and archiving
electronic data in FDA-regulated
clinical investigations. 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 to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in §§ 312.62(b) and
312.64(b) have been approved under
OMB control number 0910–0014; and
the collection of information in
§§ 812.140 and 812.150 has been
approved under OMB control number
0910–0078.
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1170-1173]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-94]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0610]
Draft Guidance for Industry on Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Postmarketing
Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic.'' The draft guidance discusses FDA's
intended approach to enforcement of adverse event reporting
requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic. The agency makes
recommendations to industry for focusing limited resources on reports
[[Page 1171]]
related to products indicated for the prevention and treatment of
influenza and other specific types of reports indicated in the draft
guidance. This draft guidance is a revision of the draft guidance for
industry of the same title published on December 16, 2008.
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 written or electronic comments on the draft guidance
by March 8, 2011. Submit written comments on the proposed collection of
information by March 8, 2011.
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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. 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:
Regarding pandemic influenza: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4146, Silver Spring, MD 20993-
0002, 301-796-8510.
Regarding human drug products: Solomon Iyasu, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4447, Silver Spring, MD 20993-0002, 301-
796-2370.
Regarding human biological products: Stephen Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
Regarding medical device products: Deborah Moore, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 3230, Silver Spring, MD 20993-0002,
301-796-6106.
Regarding dietary supplements: John Sheehan, Center for Food Safety
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1488.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Postmarketing Adverse Event Reporting for Medical
Products and Dietary Supplements During an Influenza Pandemic.'' In the
Federal Register of December 16, 2008 (73 FR 76364), FDA published
notice of the availability of a draft guidance of the same title. FDA
anticipates that during an influenza pandemic, industry and FDA
workforces may be reduced while reporting of adverse events related to
widespread use of medical products indicated for the treatment and
prevention of influenza may increase, although the extent of these
possible changes is unknown. The revised draft guidance discusses FDA's
intended approach to enforcement of adverse event reporting
requirements for drugs, biologics, medical devices, and dietary
supplements during an influenza pandemic.
II. Revisions to the 2008 Draft Guidance
FDA is issuing a revised draft guidance that includes
recommendations for planning, notification, and documentation for firms
that report postmarketing adverse events. The revised draft guidance
recommends that each firm's pandemic influenza continuity of operations
plan (COOP) include instructions for reporting adverse events and a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The revised draft guidance recommends
that firms that are unable to fulfill normal adverse event reporting
requirements during an influenza pandemic do the following:
Document the conditions that prevent them from meeting
normal reporting requirements,
Notify the appropriate FDA organizational unit responsible
for adverse event reporting compliance when these conditions exist and
when the reporting process is restored, and
Maintain records to identify what reports have been
stored.
These recommendations represent collections of information under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520)
discussed in section IV of this document. In issuing this revised draft
guidance, FDA considered all comments that were submitted in response
to the December 2008 draft guidance. Most comments requested that
greater clarity be provided in certain sections; FDA has revised these
sections accordingly.
This draft guidance does not address monitoring and reporting of
adverse events that might be imposed as a condition of authorization
for products authorized for emergency use under section 564 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb-
3). This draft guidance also does not address monitoring and reporting
of adverse events as required by regulations establishing the
conditions for investigational use of drugs, biologics, and devices.
(See 21 CFR parts 312 and 812.)
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
postmarketing adverse event reporting for medical products and dietary
supplements during pandemic influenza. 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Paperwork Reduction Act of 1995
Under the PRA, 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
this notice of the proposed collection of information set forth in this
document.
[[Page 1172]]
With respect to the collection of information associated with this
draft guidance, 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.
The draft guidance explains FDA's approach to enforcement of
adverse event reporting requirements for drugs, biologics, medical
devices, and dietary supplements during an influenza pandemic,
including an intent not to object to changes in the timing of
submission of certain reports during some stages of the pandemic
response. The Agency recommends that each firm's pandemic influenza
COOP include instructions for reporting adverse events, including a
plan for the submission of stored reports that were not submitted
within regulatory timeframes. The draft guidance explains that firms
that are unable to fulfill normal adverse event reporting requirements
during an influenza pandemic should: (1) Maintain documentation of the
conditions that prevent them from meeting normal reporting
requirements, (2) notify the appropriate FDA organizational unit
responsible for adverse event reporting compliance when the conditions
exist and when the reporting process is restored, and (3) maintain
records to identify what reports have been stored.
Based on the number of manufacturers that would be covered by the
draft guidance, we estimate that approximately 5,000 firms will add to
their COOP: (1) Instructions for reporting adverse events and (2) a
plan for submitting stored reports that were not submitted within
regulatory timeframes. We estimate that each firm will take
approximately 50 hours to prepare the adverse event reporting plan for
its COOP.
We estimate that approximately 500 firms will be unable to fulfill
normal adverse event reporting requirements because of conditions
caused by an influenza pandemic and that these firms will notify the
appropriate FDA organizational unit responsible for adverse event
reporting compliance when the conditions exist. Although we do not
anticipate such pandemic influenza conditions to occur every year, for
purposes of the PRA, we estimate that each of these firms will notify
FDA approximately once each year, and that each notification will take
approximately 8 hours to prepare and submit.
Concerning the recommendation in the draft guidance that firms
unable to fulfill normal adverse event reporting requirements maintain
documentation of the conditions that prevent them from meeting these
requirements and also maintain records to identify what adverse event
reports have been stored and when the reporting process is restored, we
estimate that approximately 500 firms will each need approximately 8
hours to maintain the documentation and that approximately 500 firms
will each need approximately 8 hours to maintain the records.
Therefore, the total recordkeeping burden that would result from the
draft guidance would be 258,000 hours.
The draft guidance also refers to previously approved collections
of information found in FDA's adverse event reporting requirements in
21 CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and
part 803. These regulations contain collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and are
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230,
0910-0308, 0910-0437, and 0910-0543. In addition, the draft guidance
also refers to adverse event reports for nonprescription human drug
products marketed without an approved application and dietary
supplements required under sections 760 and 761 of the FD&C Act (21
U.S.C. 379aa and 379aa-1), which include collections of information
approved under OMB control numbers 0910-0636 and 0910-0635.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Total Hours per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting 500 1 500 8 4,000
is not feasible................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,000
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this information collection.
Table 2--Estimated Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total records Hours per Total hours
recordkeepers recordkeeping record
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting plan 5,000 1 5,000 50 250,000
to COOP........................
Maintain documentation of 500 1 500 8 4,000
influenza pandemic conditions
and resultant high absenteeism.
Maintain records to identify 500 1 500 8 4,000
what reports have been stored
and when the reporting process
was restored...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 258,000
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this information collection.
[[Page 1173]]
V. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm,
or https://www.regulations.gov.
Dated: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-94 Filed 1-6-11; 8:45 am]
BILLING CODE 4110-01-P
