Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance), 4354-4356 [2017-00632]
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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copies of the draft guidance to the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,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Scott Goldie, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 3557, Silver Spring,
MD 20993–0002, 301–796–2055; or
Stephen Ripley, Center for Biologics
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Multiple Endpoints in Clinical Trials.’’
This guidance describes various
strategies for grouping and ordering
endpoints for analysis and applying
some well-recognized statistical
methods for managing multiplicity
within a study. FDA’s International
Conference on Harmonization (ICH)
guidance for industry ‘‘E9 Statistical
Principles for Clinical Trials’’ is a broadranging guidance that includes
discussion of multiple endpoints. This
draft guidance provides greater detail on
the topic of multiple endpoints. The
issuance of this draft guidance
represents partial fulfillment of an FDA
commitment under the Food and Drug
Administration Amendments Act of
2007. (Title I of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85)). Under section XI
(Expediting Drug Development) of the
Prescription Drug User Fee Act
(PDUFA) Performance Goals, FDA
agreed to develop and publish for
comment draft guidance on ‘‘Multiple
Endpoints in Clinical Trials,’’ and to
complete the final guidance within one
year of the close of the public comment
period of the PDUFA Performance Goals
(see https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm119243.htm).
Failure to account for multiplicity
when there are several clinical
endpoints evaluated in a study can lead
to false positive conclusions regarding
the effects of the drug. The regulatory
concern regarding multiplicity arises
principally in the evaluation of clinical
trials intended to demonstrate
effectiveness and support drug
approval; however, this issue is
important throughout the drug
development process.
The focus of this draft guidance is
control of the Type 1 error rate for the
planned primary and secondary
endpoints of a clinical trial so that the
major findings are well supported.
Multiplicity adjustments provide a
means for controlling Type 1 error when
there are multiple analyses of the drug’s
effects. The issues of multiplicity and
methods to address them are illustrated
in the draft guidance with examples of
different study endpoints. Both the
issues and methods that apply to
multiple endpoints also apply to other
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sources of multiplicity, including
multiple doses, time points, or study
population subgroups.
Once a trial is successful
(demonstrates effectiveness or ‘‘wins’’
on the primary endpoint(s)), there are
many other attributes of a drug’s effects
that may be described. Analyses that
describe these other attributes of a drug
can be informative and are often
included in physician labeling. Such
descriptive analyses are not the subject
of this draft guidance and are not
addressed in detail.
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 multiple endpoints in clinical trials.
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.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00695 Filed 1–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1496]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Rapid Response
Surveys (Generic Clearance)
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 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
E:\FR\FM\13JAN1.SGM
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the use of rapid
response surveys to obtain data on
safety information to support quick
turnaround decisionmaking about
potential safety problems or risk
management solutions from health care
professionals, hospitals, and other user
facilities (e.g., nursing homes, etc.);
consumers; manufacturers of biologics,
drugs, and medical devices; distributors;
and importers, when FDA must quickly
determine whether or not a problem
with a biologic, drug, or medical device
impacts the public health.
DATES: Submit either electronic or
written comments on the collection of
information by March 14, 2017.
ADDRESSES: You may submit comments
as follows:
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’’).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
VerDate Sep<11>2014
19:06 Jan 12, 2017
Jkt 241001
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–1496 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food and
Drug Administration Rapid Response
Surveys (Generic Clearance).’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
PO 00000
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4355
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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.
FOR FURTHER INFORMATION CONTACT:
FDA Rapid Response Surveys (Generic
Collection), OMB Control Number
0910–0500—Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355), requires that important
safety information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C.
360i), FDA is authorized to require
manufacturers to report medical device-
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
related deaths, serious injuries, and
malfunctions to FDA; to require user
facilities to report device-related deaths
directly to FDA and to manufacturers;
and to report serious injuries to the
manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to
require manufacturers to conduct
postmarket surveillance of medical
devices. Section 705(b) of the FD&C Act
(21 U.S.C. 375(b)) authorizes FDA to
collect and disseminate information
regarding medical products or cosmetics
in situations involving imminent danger
to health or gross deception of the
consumer. Section 903(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2))
authorizes the Commissioner of Food
and Drugs to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
These sections of the FD&C Act enable
FDA to enhance consumer protection
from risks associated with medical
products usage that are not foreseen or
apparent during the premarket
notification and review process. FDA’s
regulations governing application for
Agency approval to market a new drug
(21 CFR part 314) and regulations
governing biological products (21 CFR
part 600) implement these statutory
provisions. Currently, FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using FDA Forms 3500 and
3500A (OMB control number 0910–
0291) and the vaccine adverse event
reporting system.
FDA is seeking OMB clearance to
collect vital information via a series of
rapid response surveys. Participation in
these surveys will be voluntary. This
request covers rapid response surveys
for community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to quickly
obtain vital information about medical
product risks and interventions to
reduce risks so the Agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA projects 6 emergency risk related
surveys per year with a sample of
between 50 and 10,000 respondents per
survey. FDA also projects a response
time of 0.5 hour per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
may be able to obtain by working with
health care professional organizations.
The annual number of surveys was
determined by the maximum number of
surveys per year FDA has ever
conducted under this collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FDA Rapid Response Survey ..............................................
10,000
6
60,000
0.5
30,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00632 Filed 1–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1777]
Factors To Consider When Making
Benefit-Risk Determinations for
Medical Device Investigational Device
Exemptions; Guidance for
Investigational Device Exemption
Sponsors, Sponsor-Investigators, and
Food and Drug Administration Staff;
Availability
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Factors to Consider
When Making Benefit-Risk
Determinations for Medical Device
SUMMARY:
VerDate Sep<11>2014
19:06 Jan 12, 2017
Jkt 241001
Investigational Device Exemptions.’’
The purpose of this guidance is to
provide greater clarity for FDA staff and
Investigational Device Exemptions (IDE)
application sponsors and sponsorinvestigators regarding the principal
factors that the Agency considers when
assessing the benefits and risks of IDE
applications for human clinical study.
The guidance also characterizes benefits
in the context of investigational
research, which includes direct benefits
to the subjects and benefits to others.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
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’’).
Electronic Submissions
Written/Paper 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
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
PO 00000
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Fmt 4703
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13JAN1
]]>Agencies
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4354-4356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00632]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1496]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Rapid Response Surveys
(Generic Clearance)
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
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each
[[Page 4355]]
proposed collection of information, including each proposed extension
of an existing collection of information, and to allow 60 days for
public comment in response to the notice. This notice solicits comments
on the use of rapid response surveys to obtain data on safety
information to support quick turnaround decisionmaking about potential
safety problems or risk management solutions from health care
professionals, hospitals, and other user facilities (e.g., nursing
homes, etc.); consumers; manufacturers of biologics, drugs, and medical
devices; distributors; and importers, when FDA must quickly determine
whether or not a problem with a biologic, drug, or medical device
impacts the public health.
DATES: Submit either electronic or written comments on the collection
of information by March 14, 2017.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-1496 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food and Drug Administration
Rapid Response Surveys (Generic Clearance).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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.
FDA Rapid Response Surveys (Generic Collection), OMB Control Number
0910-0500--Extension
Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355), requires that important safety information
relating to all human prescription drug products be made available to
FDA so that it can take appropriate action to protect the public health
when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to
require manufacturers to report medical device-
[[Page 4356]]
related deaths, serious injuries, and malfunctions to FDA; to require
user facilities to report device-related deaths directly to FDA and to
manufacturers; and to report serious injuries to the manufacturer.
Section 522 of the FD&C Act (21 U.S.C. 360l) authorizes FDA to require
manufacturers to conduct postmarket surveillance of medical devices.
Section 705(b) of the FD&C Act (21 U.S.C. 375(b)) authorizes FDA to
collect and disseminate information regarding medical products or
cosmetics in situations involving imminent danger to health or gross
deception of the consumer. Section 903(d)(2) of the FD&C Act (21 U.S.C.
393(d)(2)) authorizes the Commissioner of Food and Drugs to implement
general powers (including conducting research) to carry out effectively
the mission of FDA. These sections of the FD&C Act enable FDA to
enhance consumer protection from risks associated with medical products
usage that are not foreseen or apparent during the premarket
notification and review process. FDA's regulations governing
application for Agency approval to market a new drug (21 CFR part 314)
and regulations governing biological products (21 CFR part 600)
implement these statutory provisions. Currently, FDA monitors medical
product related postmarket adverse events via both the mandatory and
voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A
(OMB control number 0910-0291) and the vaccine adverse event reporting
system.
FDA is seeking OMB clearance to collect vital information via a
series of rapid response surveys. Participation in these surveys will
be voluntary. This request covers rapid response surveys for community
based health care professionals, general type medical facilities,
specialized medical facilities (those known for cardiac surgery,
obstetrics/gynecology services, pediatric services, etc.), other health
care professionals, patients, consumers, and risk managers working in
medical facilities. FDA will use the information gathered from these
surveys to quickly obtain vital information about medical product risks
and interventions to reduce risks so the Agency may take appropriate
public health or regulatory action including dissemination of this
information as necessary and appropriate.
FDA projects 6 emergency risk related surveys per year with a
sample of between 50 and 10,000 respondents per survey. FDA also
projects a response time of 0.5 hour per response. These estimates are
based on the maximum sample size per questionnaire that FDA may be able
to obtain by working with health care professional organizations. The
annual number of surveys was determined by the maximum number of
surveys per year FDA has ever conducted under this collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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FDA Rapid Response Survey.......................................... 10,000 6 60,000 0.5 30,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00632 Filed 1-12-17; 8:45 am]
BILLING CODE 4164-01-P
