Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 91939-91940 [2016-30351]
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91939
Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product TRULICITY
(dulaglutide). TRULICITY is indicated
as an adjunct to diet and exercise to
improve glycemic control in adults with
type 2 diabetes mellitus. Subsequent to
this approval, the USPTO received a
patent term restoration application for
TRULICITY (U.S. Patent No. 7,452,966)
from Eli Lilly and Company, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
October 15, 2015, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
TRULICITY represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TRULICITY is 3,303 days. Of this time,
2,937 days occurred during the testing
phase of the regulatory review period,
while 366 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: September 4, 2005.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on September 4, 2005.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): September 18, 2013. The
applicant claims September 17, 2013, as
the date the biologics license
application (BLA) for TRULICITY (BLA
125469) was initially submitted.
However, FDA records indicate that
BLA 125469 was submitted on
September 18, 2013.
3. The date the application was
approved: September 18, 2014. FDA has
verified the applicant’s claim that BLA
125469 was approved on September 18,
2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,249 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30399 Filed 12–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–N–0873; FDA–
2008–D–0031; FDA–2013–N–0242; FDA–
2013–N–0125; FDA–2013–N–0093; FDA–
2016–N–1593; FDA–2015–N–2406; FDA–
2013–N–0450; FDA–2011–N–0830]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, Three White
Flint North, 11601 Landsdown St.,
North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUMMARY:
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.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Bar Code Label Requirements for Human Drug Products and Biological Products ..............................................
Clinical Laboratory Improvement Amendments Waiver Applications .....................................................................
Current Good Manufacturing Practices for Positron Emission Tomography Drugs ...............................................
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling ....
Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity
New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act ..........
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0910–0537
0910–0598
0910–0667
0910–0740
9/30/2019
9/30/2019
9/30/2019
9/30/2019
0910–0746
9/30/2019
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Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
No.
Title of collection
Medical Device Accessories ....................................................................................................................................
Market Claims in Direct-to-Consumer Prescription Drug Print Ads ........................................................................
Abbreviated New Animal Drug Applications ............................................................................................................
Abbreviated New Drug Applications and 505(b)(2) Applications ............................................................................
Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30351 Filed 12–16–16; 8:45 am]
Dated: December 13, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4164–01–P
[FR Doc. 2016–30360 Filed 12–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute Of Allergy And
Infectious Diseases; Notice of Closed
Meeting
sradovich on DSK3GMQ082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Peer Review Meeting.
Date: January 9, 2017.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Ann Marie M. Cruz, Ph.D.,
Scientific Review Officer, Program
Management & Operations Branch DEA/SRP
RM 3E71, National Institutes of Health,
NIAID, 5601 Fishers Lane, Rockville, MD
20852, 301–761–3100, AnnMarie.Cruz@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Office of the Director; Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the National
Toxicology Program Board of Scientific
Counselors was renewed for an
additional two-year period on
November 14, 2016.
It is determined that the National
Toxicology Program Board of Scientific
Counselors is in the public interest in
connection with the performance of
duties imposed on the National
Toxicology Program by law, and that
these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
Dated: December 12, 2016.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30364 Filed 12–16–16; 8:45 am]
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0910–0823
0910–0824
0910–0669
0910–0786
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9/30/2019
9/30/2019
10/31/2019
11/30/2019
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Repository Contract
Review.
Date: January 5, 2017.
Time: 10:30 a.m. to 1:45 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7353, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
arnardm@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: December 13, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30363 Filed 12–16–16; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Notices]
[Pages 91939-91940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-N-0873; FDA-2008-D-0031; FDA-2013-N-0242; FDA-
2013-N-0125; FDA-2013-N-0093; FDA-2016-N-1593; FDA-2015-N-2406; FDA-
2013-N-0450; FDA-2011-N-0830]
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, Three White Flint North, 11601 Landsdown
St., North Bethesda, MD 20852, 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
------------------------------------------------------------------------
Bar Code Label Requirements for Human 0910-0537 9/30/2019
Drug Products and Biological Products..
Clinical Laboratory Improvement 0910-0598 9/30/2019
Amendments Waiver Applications.........
Current Good Manufacturing Practices for 0910-0667 9/30/2019
Positron Emission Tomography Drugs.....
Medical Devices: Use of Certain Symbols 0910-0740 9/30/2019
in Labeling--Glossary to Support the
Use of Symbols in Labeling.............
Evaluation of the Program for Enhanced 0910-0746 9/30/2019
Review Transparency and Communication
for New Molecular Entity New Drug
Applications and Original Biologics
License Applications in Prescription
Drug User Fee Act......................
[[Page 91940]]
Medical Device Accessories.............. 0910-0823 9/30/2019
Market Claims in Direct-to-Consumer 0910-0824 9/30/2019
Prescription Drug Print Ads............
Abbreviated New Animal Drug Applications 0910-0669 10/31/2019
Abbreviated New Drug Applications and 0910-0786 11/30/2019
505(b)(2) Applications.................
------------------------------------------------------------------------
Dated: December 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30351 Filed 12-16-16; 8:45 am]
BILLING CODE 4164-01-P
