Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health, 40006 [2017-17836]
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40006
Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
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 0910–0769. Also
include the FDA docket number found
in brackets in the heading of this
document.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1095]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Submission Process for Voluntary
Allegations to the Center for Devices
and Radiological Health
AGENCY:
FOR FURTHER INFORMATION CONTACT:
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 September
22, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Electronic Submission Process for
Voluntary Allegations to the Center for
Devices and Radiological Health—OMB
Control Number 0910–0769—Extension
This information collection request
collects information voluntarily
submitted to Center for Devices and
Radiological Health (CDRH) on actual or
potential health risk concerns about a
medical device or radiological product
or its use. Because, prior to the
establishment of the electronic
submission process for voluntary
allegations to CDRH, there had been no
established guidelines or instructions on
how to submit an allegation to CDRH,
allegations often contained minimal
information and were received via
phone calls, emails, or conversationally.
CDRH has established a consistent
format and process for the submission of
device allegations that enhances our
timeliness in receiving, assessing, and
evaluating voluntary allegations. The
information provided in the allegations
received by CDRH may be used to
clarify the recurrence or emergence of
significant device-related risks to the
general public and the need to initiate
educational outreach or regulatory
action to minimize or mitigate identified
risks.
In the Federal Register of May 30,
2017 (82 FR 24716) 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:
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
Electronic submission of voluntary allegations to
CDRH.
700
1
700
.25 (15 minutes) ..........
175
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17836 Filed 8–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[Docket No. FDA–2010–N–0493]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Additional Criteria
and Procedures for Classifying Overthe-Counter Drugs as Generally
Recognized as Safe and Effective and
Not Misbranded
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
16:47 Aug 22, 2017
Jkt 241001
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 September
22, 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 0910–0688. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
SUMMARY:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded—21 CFR
330.14, OMB Control Number 0910–
0688—Revision
This information collection supports
Agency regulations. Specifically, FDA
regulations at § 330.14 (21 CFR 330.14)
establish additional criteria and
procedures for classifying over-thecounter (OTC) drugs as generally
recognized as safe and effective and not
misbranded. These regulations state that
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17836]
[[Page 40006]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1095]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic Submission
Process for Voluntary Allegations to the Center for Devices and
Radiological Health
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
September 22, 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 0910-0769.
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.
Electronic Submission Process for Voluntary Allegations to the Center
for Devices and Radiological Health--OMB Control Number 0910-0769--
Extension
This information collection request collects information
voluntarily submitted to Center for Devices and Radiological Health
(CDRH) on actual or potential health risk concerns about a medical
device or radiological product or its use. Because, prior to the
establishment of the electronic submission process for voluntary
allegations to CDRH, there had been no established guidelines or
instructions on how to submit an allegation to CDRH, allegations often
contained minimal information and were received via phone calls,
emails, or conversationally. CDRH has established a consistent format
and process for the submission of device allegations that enhances our
timeliness in receiving, assessing, and evaluating voluntary
allegations. The information provided in the allegations received by
CDRH may be used to clarify the recurrence or emergence of significant
device-related risks to the general public and the need to initiate
educational outreach or regulatory action to minimize or mitigate
identified risks.
In the Federal Register of May 30, 2017 (82 FR 24716) 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
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of voluntary 700 1 700 .25 (15 minutes)......................... 175
allegations to CDRH.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17836 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P
