Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance), 28074-28075 [2017-12782]
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28074
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
No. of
responses
per
respondent
Total
annual
responses
Hours per
response
Total hours
125
2.20
275
32
8,800
PFC ......................................................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
FOR FURTHER INFORMATION CONTACT:
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12836 Filed 6–19–17; 8:45 am]
FDA Rapid Response Surveys (Generic
Collection)
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; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 20,
2017.
SUMMARY:
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0500. Also
include the FDA docket number found
in brackets in the heading of this
document.
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
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.
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 devicerelated 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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.
In the Federal Register of January 13,
2017 (82 FR 4354), FDA published a 60day 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:
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
28075
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
FDA Rapid Response Survey ..................................
1There
6
service acceptance receipt is on or
before that date.
[FR Doc. 2017–12782 Filed 6–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1072]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Application for
Participation in Food and Drug
Administration Fellowship Programs
AGENCY:
Food and Drug Administration,
HHS.
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 ‘‘Application for
Participation in FDA Fellowship
Programs.’’
SUMMARY:
Submit either electronic or
written comments on the collection of
information by August 21, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 21, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
DATES:
sradovich on DSK3GMQ082PROD with NOTICES
10,000
Total
annual
responses
60,000
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.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
ACTION:
Number of
responses
per
respondent
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–1072 for ‘‘Application for
Participation in Food and Drug
Administration Fellowship Programs.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
E:\FR\FM\20JNN1.SGM
20JNN1
]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28074-28075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1496]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July
20, 2017.
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 emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0500.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@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.
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-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. 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.
In the Federal Register of January 13, 2017 (82 FR 4354), 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:
[[Page 28075]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Rapid Response Survey................... 10,000 6 60,000 0.5 (30 minutes).......................... 30,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12782 Filed 6-19-17; 8:45 am]
BILLING CODE 4164-01-P
