80 FR 26276 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26276-26276
FR Document		2015-10997

The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Page 26276]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Premarket Notification for a New 
Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled, ``Premarket Notification for a New 
Dietary Ingredient'' has 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: On February 27, 2015, the Agency submitted a 
proposed collection of information entitled, ``Premarket Notification 
for a New Dietary Ingredient'' to OMB for review and clearance under 44 
U.S.C. 3507. 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. OMB has now approved the 
information collection and has assigned OMB control number 0910-0330. 
The approval expires on March 31, 2018. A copy of the supporting 
statement for this information collection is available on the Internet 
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10997 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

26276 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

1. The date an exemption under available on http://www.regulations.gov DEPARTMENT OF HEALTH AND
section 520(g) of the Federal Food, Drug, may be viewed in the Division of HUMAN SERVICES
and Cosmetic Act (the FD&C Act) (21 Dockets Management between 9 a.m.
U.S.C. 360j(g)) involving this device and 4 p.m., Monday through Friday. Food and Drug Administration
became effective: April 30, 2008. FDA Dated: May 1, 2015. [Docket No. FDA–2014–E–0100]
has verified the applicant’s claim that Leslie Kux,
the date the investigational device Determination of Regulatory Review
Associate Commissioner for Policy.
exemption required under section Period for Purposes of Patent
520(g) of the FD&C act for human tests [FR Doc. 2015–11001 Filed 5–6–15; 8:45 am]
Extension; SIGNIFOR
to begin became effective April 30, BILLING CODE 4164–01–P

2008. AGENCY: Food and Drug Administration,
2. The date an application was HHS.
initially submitted with respect to the DEPARTMENT OF HEALTH AND ACTION: Notice.
device under section 515 of the FD& C HUMAN SERVICES
Act (21 U.S.C. 360e): December 28, SUMMARY: The Food and Drug
2010. The applicant claims December Food and Drug Administration Administration (FDA) has determined
23, 2010, as the date the premarket the regulatory review period for
approval application (PMA) for HVAD [Docket No. FDA–2013–N–0878] SIGNIFOR and is publishing this notice
ROTARY BLOOD PUMP (PMA of that determination as required by
P100047) was initially submitted. Agency Information Collection law. FDA has made the determination
However, FDA records indicate that Activities; Announcement of Office of because of the submission of an
PMA P100047 was submitted on Management and Budget Approval; application to the Director of the U.S.
December 28, 2010. Premarket Notification for a New Patent and Trademark Office (USPTO),
3. The date the application was Dietary Ingredient Department of Commerce, for the
approved: November 20, 2012. FDA has extension of a patent which claims that
verified the applicant’s claim that PMA AGENCY: Food and Drug Administration, human drug product.
P100047 was approved on November HHS.
ADDRESSES: Submit electronic
20, 2012. ACTION: Notice. comments to http://
This determination of the regulatory www.regulations.gov. Submit written
review period establishes the maximum SUMMARY: The Food and Drug petitions (two copies are required) and
potential length of a patent extension. Administration (FDA) is announcing written comments to the Division of
However, the USPTO applies several that a collection of information entitled, Dockets Management (HFA–305), Food
statutory limitations in its calculations ‘‘Premarket Notification for a New and Drug Administration, 5630 Fishers
of the actual period for patent extension. Dietary Ingredient’’ has been approved Lane, Rm. 1061, Rockville, MD 20852.
In its application for patent extension, by the Office of Management and Submit petitions electronically to
this applicant seeks 818 days of patent Budget (OMB) under the Paperwork http://www.regulations.gov at Docket
term extension. Reduction Act of 1995. No. FDA–2013–S–0610.
Anyone with knowledge that any of
FOR FURTHER INFORMATION CONTACT: FDA FOR FURTHER INFORMATION CONTACT:
the dates as published are incorrect may
PRA Staff, Office of Operations, Food Beverly Friedman, Office of
submit to the Division of Dockets
Management (see ADDRESSES) either and Drug Administration, 8455 Management, Food and Drug
electronic or written comments and ask Colesville Rd., COLE–14526, Silver Administration, 10001 New Hampshire
for a redetermination by July 6, 2015. Spring, MD 20993–0002, PRAStaff@ Ave., Hillandale Campus, Rm. 3180,
Furthermore, any interested person may fda.hhs.gov. Silver Spring, MD 20993, 301–796–
petition FDA for a determination 7900.
SUPPLEMENTARY INFORMATION: On
regarding whether the applicant for February 27, 2015, the Agency SUPPLEMENTARY INFORMATION: The Drug
extension acted with due diligence submitted a proposed collection of Price Competition and Patent Term
during the regulatory review period by information entitled, ‘‘Premarket Restoration Act of 1984 (Pub. L. 98–417)
November 3, 2015. To meet its burden, Notification for a New Dietary and the Generic Animal Drug and Patent
the petition must contain sufficient facts Ingredient’’ to OMB for review and Term Restoration Act (Pub. L. 100–670)
to merit an FDA investigation. (See H. clearance under 44 U.S.C. 3507. An generally provide that a patent may be
Rept. 857, part 1, 98th Cong., 2d sess., Agency may not conduct or sponsor, extended for a period of up to 5 years
pp. 41–42, 1984.) Petitions should be in and a person is not required to respond so long as the patented item (human
the format specified in 21 CFR 10.30. to, a collection of information unless it drug product, animal drug product,
Interested persons may submit to the displays a currently valid OMB control medical device, food additive, or color
Division of Dockets Management (see number. OMB has now approved the additive) was subject to regulatory
ADDRESSES) electronic or written information collection and has assigned review by FDA before the item was
comments and written or electronic OMB control number 0910–0330. The marketed. Under these acts, a product’s
petitions. It is only necessary to send approval expires on March 31, 2018. A regulatory review period forms the basis
one set of comments. Identify comments copy of the supporting statement for this for determining the amount of extension
with the docket number found in information collection is available on an applicant may receive.
mstockstill on DSK4VPTVN1PROD with NOTICES

brackets in the heading of this the Internet at http://www.reginfo.gov/ A regulatory review period consists of
document. If you submit a written public/do/PRAMain. two periods of time: A testing phase and
petition, two copies are required. A an approval phase. For human drug
petition submitted electronically must Dated: May 4, 2015. products, the testing phase begins when
be submitted to http:// Leslie Kux, the exemption to permit the clinical
www.regulations.gov, Docket No. FDA– Associate Commissioner for Policy. investigations of the drug becomes
2013–S–0610. Comments and petitions [FR Doc. 2015–10997 Filed 5–6–15; 8:45 am] effective and runs until the approval
that have not been made publicly BILLING CODE 4164–01–P phase begins. The approval phase starts

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Document Created: 2015-12-16 07:50:36
Document Modified: 2015-12-16 07:50:36

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		80 FR 26276

80 FR 26276 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration