Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 21355-21356 [2016-08153]
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21355
Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
the firms whose devices had been
detained.
In the Federal Register of October 19,
2015 (80 FR 63232), 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
responses per
respondent
Number of
respondents
21 CFR Section
Total
annual
responses
Average
burden per
response
Total hours
800.55(g) ..............................................................................
895.21(d)(8) and 895.22(a) ..................................................
1
26
1
1
1
26
25
16
25
416
Total ..............................................................................
........................
........................
........................
........................
441
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
800.55(k) ..............................................................................
1 There
1
Total
annual
records
1
Average
burden per
recordkeeping
1
20
Total hours
20
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–N–0564, FDA–
2015–N–0797, FDA–2012–N–0021, FDA–
2012–N–0280, FDA–2007–D–0372, FDA–
2014–D–0044]
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the Internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
HHS.
Notice.
SUMMARY:
[FR Doc. 2016–08161 Filed 4–8–16; 8:45 am]
AGENCY:
Number of
records per
recordkeeper
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
mstockstill on DSK4VPTVN1PROD with NOTICES
Title of collection
Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act .......................................................................................................................................................
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ......................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Financial Disclosure by Clinical Investigators .........................................................................................................
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act ..........................................................................................
Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records ...............................................................................................................
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Date approval
expires
0910–0642
0910–0752
0910–0342
0910–0396
2/28/2019
2/28/2019
3/31/2019
3/31/2019
0910–0635
3/31/2019
0910–0811
3/31/2019
21356
Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices
Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0511. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2016–08153 Filed 4–8–16; 8:45 am]
BILLING CODE 4164–01–P
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0536]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
User Fee Cover Sheet, Form FDA 3601
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 May 11,
2016.
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_
ADDRESSES:
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:
Medical Device User Fee Cover Sheet,
Form FDA 3601—OMB Control Number
0910–0511—Extension
The Federal Food, Drug, and Cosmetic
Act, as amended by the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250), and the Medical
Device User Fee Amendments of 2007
(Title II of the Food and Drug
Administration Amendments Act of
2007), authorizes FDA to collect user
fees for certain medical device
applications. Under this authority,
companies pay a fee for certain new
medical device applications or
supplements submitted to the Agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
Medical Device User Fee Cover Sheet, is
designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to account for
and track user fees. The form provides
a cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health and the Center for Biologics
Evaluation and Research to initiate the
administrative screening of new medical
device applications and supplemental
applications.
The total number of annual responses
is based on the average number of cover
sheet submissions received by FDA in
recent years. The number of received
annual responses includes cover sheets
for applications that were qualified for
small businesses and fee waivers or
reductions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions, and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates
(18 minutes).
In the Federal Register of October 21,
2015 (80 FR 63793), 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
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
3601 ..................................................................................
5,214
1
5,214
1There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
AGENCY:
Notice of meeting.
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This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The
Advisory Council will spend the
majority of the April meeting
considering recommendations made by
each of the three subcommittees for
updates to the 2016 National Plan.
Additional presentations in the
afternoon will include an update on the
SUMMARY:
[FR Doc. 2016–08154 Filed 4–8–16; 8:45 am]
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0.30 (18 minutes).
Total hours
1,564
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
Average burden
per response
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Dementia Friendly America campaign,
planning progress towards a Care and
Services Summit, and federal
workgroup updates.
DATES: The meeting will be held on
April 29, 2016 from 9 a.m. to 5 p.m.
EDT.
The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW., Washington, DC 20201.
Comments: Time is allocated in the
afternoon on the agenda to hear public
comments. The time for oral comments
will be limited to two (2) minutes per
individual. In lieu of oral comments,
ADDRESSES:
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]]>Agencies
[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Notices]
[Pages 21355-21356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-N-0564, FDA-2015-N-0797, FDA-2012-N-0021, FDA-
2012-N-0280, FDA-2007-D-0372, FDA-2014-D-0044]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the Internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Labeling of Dietary Supplements as 0910-0642 2/28/2019
Required by the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act.........................
Foreign Supplier Verification Programs 0910-0752 2/28/2019
for Importers of Food for Humans and
Animals................................
Substances Generally Recognized as Safe: 0910-0342 3/31/2019
Notification Procedure.................
Financial Disclosure by Clinical 0910-0396 3/31/2019
Investigators..........................
Adverse Event Reporting and 0910-0635 3/31/2019
Recordkeeping for Dietary Supplements
as Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act.........................
Exempt Infant Formula Production: 0910-0811 3/31/2019
Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures,
Conduct of Audits, and Records.........
------------------------------------------------------------------------
[[Page 21356]]
Dated: April 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08153 Filed 4-8-16; 8:45 am]
BILLING CODE 4164-01-P
