Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys, 6559-6561 [2020-02240]
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<![CDATA[
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Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total
annual
responses
Average
burden per
response
Total
hours
Subsequent Year VQIP Application .....................................
Request to Reinstate Participation ......................................
200
2
1
1
200
2
20
10
4,000
20
Total ..............................................................................
........................
........................
........................
........................
4,020
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance states that each VQIP
participant will submit to FDA a notice
of intent to participate in VQIP on an
annual basis. Based on a review of the
information collection since our last
request for OMB approval, we have
made no adjustments to our annual
reporting burden estimate. We expect
that each of the expected 200 importers
in VQIP would apply in the subsequent
year to participate in VQIP. We expect
that an application to participate in
VQIP in a subsequent year will take
significantly less time to prepare than
the initial application. We use 25
percent of the amount of effort to
prepare and submit the initial
application for acceptance in VQIP.
Therefore, it is expected that, on
average, each VQIP importer will spend
20 hours to complete and submit a VQIP
application for each subsequent year.
The annual burden of completing a
subsequent year application to
participate in VQIP status by 200
importers is estimated at 4,000 hours
(200 applications × 20 hours/
application) (see table 4).
Finally, we have added to the VQIP
estimated annual reporting burden an
estimate of the burden associated with
importers’ requests to reinstate
participation in VQIP after their
participation is revoked. We believe
most participants will not need to use
this provision, and we have included an
estimate that reflects this. Upon
implementation of the VQIP, we will
reevaluate our estimate for future OMB
submission and revise it accordingly.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02248 Filed 2–4–20; 8:45 am]
BILLING CODE 4164–01–P
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Number of
responses per
respondent
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0257]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Rapid Response
Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the use of rapid
response surveys to obtain data on
safety information to support quick
turnaround decision making about
potential safety problems or risk
management solutions from healthcare
professionals, hospitals, and other user
facilities (i.e., nursing homes, etc.);
consumers; manufacturers of biologics,
drugs, food, dietary supplements,
cosmetics, animal food and feed, and
medical devices; distributors; and
importers, when FDA must quickly
determine whether or not a problem
with a biologic, drug, food, cosmetic,
dietary supplement, animal food and
feed, or medical device impacts the
public health.
DATES: Submit either electronic or
written comments on the collection of
information by April 6, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 6, 2020.
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
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The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 6, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
E:\FR\FM\05FEN1.SGM
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Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–0257 for ‘‘Agency Information
Collection Actitivites; Proposed
Collection; Comment Request; Food and
Drug Administration Rapid Response
Surveys.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
VerDate Sep<11>2014
18:54 Feb 04, 2020
Jkt 250001
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), 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.
SUPPLEMENTARY INFORMATION:
FDA Rapid Response Surveys OMB
Control Number 0910–0500—Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (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 the Agency 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-related deaths, serious injuries,
and malfunctions to FDA; to require
user facilities to report device-related
deaths directly to FDA and to
PO 00000
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Fmt 4703
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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 1003(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. FDA’s regulations governing
Agency oversight of Foods, Cosmetics,
Dietary Supplements, and Animal Food
and Feed (21 CFR parts 70 through 199)
also implement these statutory
provisions. Currently, FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using Forms FDA 3500 and
3500A (OMB control number 0910–
0291), electronic Safety Reporting Portal
(OMB control number 0910–0645), and
the vaccine adverse event reporting
system.
FDA is seeking extension of OMB
approval 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
healthcare professionals, general type
medical facilities, specialized medical
facilities (those known for cardiac
surgery, obstetrics/gynecology services,
pediatric services, etc.), other healthcare
professionals, patients, consumers, and
risk managers working in facilities
containing products related to or
regulated by FDA. 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 six emergency risk
related surveys per year with a sample
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Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
of between 50 and 10,000 respondents
per survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
may be able to obtain by working with
healthcare professional organizations.
The annual number of surveys was
determined by the maximum past
number of surveys per year FDA has
conducted under this collection.
Respondents to this collection of
information will be identified when
additional surveillance data will
address a potential public health
hazard. For example, respondents could
include facilities or professionals that
have the most experience in the use of
certain FDA-regulated products, foods,
cosmetics, dietary supplements, animal
6561
food and feed, drugs, tobacco products,
etc. Once FDA identifies the need for
additional surveillance data to address a
potential public health hazard, the
appropriate respondents will be
identified either through FDA’s lists or
through the appropriate professional
organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Rapid Response Survey .............................
1 There
Dated: January 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02240 Filed 2–4–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–5404]
Mucopolysaccharidosis Type III
(Sanfilippo Syndrome): Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Mucopolysaccharidosis Type III
(Sanfilippo Syndrome): Developing
Drugs for Treatment.’’ The purpose of
this draft guidance is to foster greater
efficiency in drug development in this
rare disease with the goal of enhancing
clinical trial data quality and supporting
the development of treatments for
mucopolysaccharidosis type III.
Specifically, the draft guidance provides
the Agency’s current recommendations
regarding eligibility criteria, trial design
considerations, and efficacy endpoints
for use in clinical development
programs of investigational drugs to
treat mucopolysaccharidosis type III.
SUMMARY:
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60,000
VerDate Sep<11>2014
18:54 Feb 04, 2020
Submit either electronic or
written comments on the draft guidance
by May 5, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
Electronic Submissions
BILLING CODE 4164–01–P
ACTION:
10,000
Total annual
responses
Average burden
per response
0.5 (30 minutes) .............
Total hours
30,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Jkt 250001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–5404 for
‘‘Mucopolysaccharidosis Type III
(Sanfilippo Syndrome): Developing
Drugs for Treatment.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
E:\FR\FM\05FEN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6559-6561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02240]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0257]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Rapid Response Surveys
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the use of rapid response surveys to obtain
data on safety information to support quick turnaround decision making
about potential safety problems or risk management solutions from
healthcare professionals, hospitals, and other user facilities (i.e.,
nursing homes, etc.); consumers; manufacturers of biologics, drugs,
food, dietary supplements, cosmetics, animal food and feed, and medical
devices; distributors; and importers, when FDA must quickly determine
whether or not a problem with a biologic, drug, food, cosmetic, dietary
supplement, animal food and feed, or medical device impacts the public
health.
DATES: Submit either electronic or written comments on the collection
of information by April 6, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and
[[Page 6560]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-N-0257 for ``Agency Information Collection Actitivites;
Proposed Collection; Comment Request; Food and Drug Administration
Rapid Response Surveys.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 OMB Control Number 0910-0500--Extension
Section 505 of the Federal Food, Drug, and Cosmetic Act (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
the Agency 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-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 1003(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. FDA's
regulations governing Agency oversight of Foods, Cosmetics, Dietary
Supplements, and Animal Food and Feed (21 CFR parts 70 through 199)
also implement these statutory provisions. Currently, FDA monitors
medical product related postmarket adverse events via both the
mandatory and voluntary MedWatch reporting systems using Forms FDA 3500
and 3500A (OMB control number 0910-0291), electronic Safety Reporting
Portal (OMB control number 0910-0645), and the vaccine adverse event
reporting system.
FDA is seeking extension of OMB approval 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 healthcare professionals, general type
medical facilities, specialized medical facilities (those known for
cardiac surgery, obstetrics/gynecology services, pediatric services,
etc.), other healthcare professionals, patients, consumers, and risk
managers working in facilities containing products related to or
regulated by FDA. 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 six emergency risk related surveys per year with a
sample
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of between 50 and 10,000 respondents per survey. FDA also projects a
response time of 0.5 hours per response. These estimates are based on
the maximum sample size per questionnaire that FDA may be able to
obtain by working with healthcare professional organizations. The
annual number of surveys was determined by the maximum past number of
surveys per year FDA has conducted under this collection.
Respondents to this collection of information will be identified
when additional surveillance data will address a potential public
health hazard. For example, respondents could include facilities or
professionals that have the most experience in the use of certain FDA-
regulated products, foods, cosmetics, dietary supplements, animal food
and feed, drugs, tobacco products, etc. Once FDA identifies the need
for additional surveillance data to address a potential public health
hazard, the appropriate respondents will be identified either through
FDA's lists or through the appropriate professional organizations.
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 per response Total hours
respondents respondent responses
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FDA Rapid Response Survey................. 10,000 6 60,000 0.5 (30 minutes)............................ 30,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: January 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02240 Filed 2-4-20; 8:45 am]
BILLING CODE 4164-01-P
