81 FR 21355 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 69 (April 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 69 (April 11, 2016)
| Page Range | 21355-21356 | |
| FR Document | 2016-08153 |
[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)] [Notices] [Pages 21355-21356] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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 http://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
![Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices 21355
year. Each administrative detention will based on FDA’s discussion with one of comment on the proposed collection of
have varying amounts of data and the firms whose devices had been information. No comments were
information that must be maintained. detained. received.
FDA’s estimate of the burden under the In the Federal Register of October 19,
FDA estimates the burden of this
administrative detention provision is 2015 (80 FR 63232), FDA published a
collection of information as follows:
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR Section responses per annual burden per Total hours
respondents respondent responses response
800.55(g) .............................................................................. 1 1 1 25 25
895.21(d)(8) and 895.22(a) .................................................. 26 1 26 16 416
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 Total Average
Number of
21 CFR Section records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
800.55(k) .............................................................................. 1 1 1 20 20
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 5, 2016. ACTION: Notice. each information collection are shown
Leslie Kux, in table 1. Copies of the supporting
Associate Commissioner for Policy. SUMMARY: The Food and Drug statements for the information
Administration (FDA) is publishing a collections are available on the Internet
[FR Doc. 2016–08161 Filed 4–8–16; 8:45 am]
list of information collections that have
BILLING CODE 4164–01–P at http://www.reginfo.gov/public/do/
been approved by the Office of
PRAMain. An Agency may not conduct
Management and Budget (OMB) under
or sponsor, and a person is not required
DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995.
to respond to, a collection of
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: FDA
information unless it displays a
PRA Staff, Office of Operations, Food
currently valid OMB control number.
Food and Drug Administration and Drug Administration, 8455
[Docket Nos. FDA–2012–N–0564, FDA–
Colesville Rd., COLE–14526, Silver
2015–N–0797, FDA–2012–N–0021, FDA– Spring, MD 20993–0002, PRAStaff@
2012–N–0280, FDA–2007–D–0372, FDA– fda.hhs.gov.
2014–D–0044] SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
Agency Information Collection
collections recently approved by OMB
Activities; Announcement of Office of
under section 3507 of the Paperwork
Management and Budget Approvals
Reduction Act of 1995 (44 U.S.C. 3507).
AGENCY: Food and Drug Administration, The OMB control number and
HHS. expiration date of OMB approval for
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires
Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act ....................................................................................................................................................... 0910–0642 2/28/2019
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals ...................................... 0910–0752 2/28/2019
Substances Generally Recognized as Safe: Notification Procedure ...................................................................... 0910–0342 3/31/2019
Financial Disclosure by Clinical Investigators ......................................................................................................... 0910–0396 3/31/2019
Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act .......................................................................................... 0910–0635 3/31/2019
mstockstill on DSK4VPTVN1PROD with NOTICES
Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Proce-
dures, Conduct of Audits, and Records ............................................................................................................... 0910–0811 3/31/2019
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![21356 Federal Register / Vol. 81, No. 69 / Monday, April 11, 2016 / Notices
Dated: April 5, 2016. submission@omb.eop.gov. All Medical Device User Fee Cover Sheet, is
Leslie Kux, comments should be identified with the designed to provide the minimum
Associate Commissioner for Policy. OMB control number 0910–0511. Also necessary information to determine
[FR Doc. 2016–08153 Filed 4–8–16; 8:45 am] include the FDA docket number found whether a fee is required for review of
BILLING CODE 4164–01–P
in brackets in the heading of this an application, to determine the amount
document. of the fee required, and to account for
and track user fees. The form provides
FOR FURTHER INFORMATION CONTACT: FDA
DEPARTMENT OF HEALTH AND a cross-reference between the fees
PRA Staff, Office of Operations, Food
HUMAN SERVICES submitted for an application with the
and Drug Administration, 8455
actual submitted application by using a
Food and Drug Administration Colesville Rd., COLE–14526, Silver
unique number tracking system. The
Spring, MD 20993–0002, PRAStaff@
[Docket No. FDA–2012–N–0536] information collected is used by FDA’s
fda.hhs.gov.
Center for Devices and Radiological
Agency Information Collection SUPPLEMENTARY INFORMATION: In Health and the Center for Biologics
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA Evaluation and Research to initiate the
Management and Budget Review; has submitted the following proposed administrative screening of new medical
Comment Request; Medical Device collection of information to OMB for device applications and supplemental
User Fee Cover Sheet, Form FDA 3601 review and clearance. applications.
The total number of annual responses
AGENCY: Food and Drug Administration, Medical Device User Fee Cover Sheet,
is based on the average number of cover
HHS. Form FDA 3601—OMB Control Number
sheet submissions received by FDA in
ACTION: Notice. 0910–0511—Extension
recent years. The number of received
The Federal Food, Drug, and Cosmetic annual responses includes cover sheets
SUMMARY: The Food and Drug
Act, as amended by the Medical Device for applications that were qualified for
Administration (FDA) is announcing
User Fee and Modernization Act of 2002 small businesses and fee waivers or
that a proposed collection of
(Pub. L. 107–250), and the Medical reductions. The estimated hours per
information has been submitted to the
Device User Fee Amendments of 2007 response are based on past FDA
Office of Management and Budget
(Title II of the Food and Drug experience with the various cover sheet
(OMB) for review and clearance under
Administration Amendments Act of submissions, and range from 5 to 30
the Paperwork Reduction Act of 1995.
2007), authorizes FDA to collect user minutes. The hours per response are
DATES: Fax written comments on the fees for certain medical device based on the average of these estimates
collection of information by May 11, applications. Under this authority, (18 minutes).
2016. companies pay a fee for certain new In the Federal Register of October 21,
ADDRESSES: To ensure that comments on medical device applications or 2015 (80 FR 63793), FDA published a
the information collection are received, supplements submitted to the Agency 60-day notice requesting public
OMB recommends that written for review. Because the submission of comment on the proposed collection of
comments be faxed to the Office of user fees concurrently with applications information. No comments were
Information and Regulatory Affairs, and supplements is required, the review received.
OMB, Attn: FDA Desk Officer, FAX: of an application cannot begin until the FDA estimates the burden of this
202–395–7285, or emailed to oira_ fee is submitted. Form FDA 3601, the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
FDA form No. responses per Total hours
respondents responses per response
respondent
3601 .................................................................................. 5,214 1 5,214 0.30 (18 min- 1,564
utes).
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 5, 2016. SUMMARY: This notice announces the Dementia Friendly America campaign,
Leslie Kux, public meeting of the Advisory Council planning progress towards a Care and
Associate Commissioner for Policy. on Alzheimer’s Research, Care, and Services Summit, and federal
[FR Doc. 2016–08154 Filed 4–8–16; 8:45 am] Services (Advisory Council). The workgroup updates.
BILLING CODE 4164–01–P
Advisory Council on Alzheimer’s DATES: The meeting will be held on
Research, Care, and Services provides April 29, 2016 from 9 a.m. to 5 p.m.
advice on how to prevent or reduce the EDT.
DEPARTMENT OF HEALTH AND burden of Alzheimer’s disease and
HUMAN SERVICES related dementias on people with the ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
mstockstill on DSK4VPTVN1PROD with NOTICES
disease and their caregivers. The
Advisory Council on Alzheimer’s Advisory Council will spend the Building, 200 Independence Avenue
Research, Care, and Services; Meeting majority of the April meeting SW., Washington, DC 20201.
considering recommendations made by Comments: Time is allocated in the
AGENCY: Assistant Secretary for each of the three subcommittees for afternoon on the agenda to hear public
Planning and Evaluation, HHS. updates to the 2016 National Plan. comments. The time for oral comments
Additional presentations in the will be limited to two (2) minutes per
ACTION: Notice of meeting.
afternoon will include an update on the individual. In lieu of oral comments,
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Document Created: 2016-04-09 00:11:00
Document Modified: 2016-04-09 00:11:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 21355 |
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