81 FR 91939 - 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 243 (December 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 243 (December 19, 2016)
| Page Range | 91939-91940 | |
| FR Document | 2016-30351 |
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)] [Notices] [Pages 91939-91940] From the Federal Register Online [www.thefederalregister.org] [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, [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 ------------------------------------------------------------------------ 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
![Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices 91939
an approval phase. For human 1. The date an exemption under 5630 Fishers Lane, Rm. 1061, Rockville,
biological products, the testing phase section 505(i) of the Federal Food, Drug, MD 20852.
begins when the exemption to permit and Cosmetic Act (21 U.S.C. 355(i)) Dated: December 14, 2016.
the clinical investigations of the became effective: September 4, 2005. Leslie Kux,
biological becomes effective and runs FDA has verified the applicant’s claim
Associate Commissioner for Policy.
until the approval phase begins. The that the date the investigational new
drug application became effective was [FR Doc. 2016–30399 Filed 12–16–16; 8:45 am]
approval phase starts with the initial
submission of an application to market on September 4, 2005. BILLING CODE 4164–01–P
the human biological product and 2. The date the application was
continues until FDA grants permission initially submitted with respect to the
human biological product under section DEPARTMENT OF HEALTH AND
to market the biological product.
351 of the Public Health Service Act (42 HUMAN SERVICES
Although only a portion of a regulatory
review period may count toward the U.S.C. 262): September 18, 2013. The
Food and Drug Administration
actual amount of extension that the applicant claims September 17, 2013, as
Director of USPTO may award (for the date the biologics license
application (BLA) for TRULICITY (BLA [Docket Nos. FDA–2012–N–0873; FDA–
example, half the testing phase must be 2008–D–0031; FDA–2013–N–0242; FDA–
subtracted as well as any time that may 125469) was initially submitted.
2013–N–0125; FDA–2013–N–0093; FDA–
have occurred before the patent was However, FDA records indicate that 2016–N–1593; FDA–2015–N–2406; FDA–
issued), FDA’s determination of the BLA 125469 was submitted on 2013–N–0450; FDA–2011–N–0830]
length of a regulatory review period for September 18, 2013.
a human biological product will include 3. The date the application was Agency Information Collection
all of the testing phase and approval approved: September 18, 2014. FDA has Activities; Announcement of Office of
phase as specified in 35 U.S.C. verified the applicant’s claim that BLA Management and Budget Approvals
156(g)(1)(B). 125469 was approved on September 18,
2014. AGENCY: Food and Drug Administration,
FDA has approved for marketing the HHS.
This determination of the regulatory
human biologic product TRULICITY
review period establishes the maximum ACTION: Notice.
(dulaglutide). TRULICITY is indicated
potential length of a patent extension.
as an adjunct to diet and exercise to However, the USPTO applies several SUMMARY: The Food and Drug
improve glycemic control in adults with statutory limitations in its calculations Administration (FDA) is publishing a
type 2 diabetes mellitus. Subsequent to of the actual period for patent extension. list of information collections that have
this approval, the USPTO received a In its application for patent extension, been approved by the Office of
patent term restoration application for this applicant seeks 1,249 days of patent Management and Budget (OMB) under
TRULICITY (U.S. Patent No. 7,452,966) term extension. the Paperwork Reduction Act of 1995.
from Eli Lilly and Company, and the
III. Petitions FOR FURTHER INFORMATION CONTACT: FDA
USPTO requested FDA’s assistance in
determining this patent’s eligibility for PRA Staff, Office of Operations, Food
Anyone with knowledge that any of and Drug Administration, Three White
patent term restoration. In a letter dated the dates as published are incorrect may
October 15, 2015, FDA advised the Flint North, 11601 Landsdown St.,
submit either electronic or written North Bethesda, MD 20852,
USPTO that this human biological comments and ask for a redetermination
product had undergone a regulatory PRAStaff@fda.hhs.gov.
(see DATES). Furthermore, any interested
review period and that the approval of person may petition FDA for a SUPPLEMENTARY INFORMATION: The
TRULICITY represented the first determination regarding whether the following is a list of FDA information
permitted commercial marketing or use applicant for extension acted with due collections recently approved by OMB
of the product. Thereafter, the USPTO diligence during the regulatory review under section 3507 of the Paperwork
requested that FDA determine the period. To meet its burden, the petition Reduction Act of 1995 (44 U.S.C. 3507).
product’s regulatory review period. must be timely (see DATES) and contain The OMB control number and
sufficient facts to merit an FDA expiration date of OMB approval for
II. Determination of Regulatory Review
investigation. (See H. Rept. 857, part 1, each information collection are shown
Period
98th Cong., 2d sess., pp. 41–42, 1984.) in table 1. Copies of the supporting
FDA has determined that the Petitions should be in the format statements for the information
applicable regulatory review period for specified in 21 CFR 10.30. collections are available on the Internet
TRULICITY is 3,303 days. Of this time, Submit petitions electronically to at http://www.reginfo.gov/public/do/
2,937 days occurred during the testing https://www.regulations.gov at Docket PRAMain. An Agency may not conduct
phase of the regulatory review period, No. FDA–2013–S–0610. Submit written or sponsor, and a person is not required
while 366 days occurred during the petitions (two copies are required) to the to respond to, a collection of
approval phase. These periods of time Division of Dockets Management (HFA– information unless it displays a
were derived from the following dates: 305), Food and Drug Administration, currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
sradovich on DSK3GMQ082PROD with NOTICES
Title of collection No. expires
Bar Code Label Requirements for Human Drug Products and Biological Products .............................................. 0910–0537 9/30/2019
Clinical Laboratory Improvement Amendments Waiver Applications ..................................................................... 0910–0598 9/30/2019
Current Good Manufacturing Practices for Positron Emission Tomography Drugs ............................................... 0910–0667 9/30/2019
Medical Devices: Use of Certain Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling .... 0910–0740 9/30/2019
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 .......... 0910–0746 9/30/2019
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![91940 Federal Register / Vol. 81, No. 243 / Monday, December 19, 2016 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control Date approval
Title of collection No. expires
Medical Device Accessories .................................................................................................................................... 0910–0823 9/30/2019
Market Claims in Direct-to-Consumer Prescription Drug Print Ads ........................................................................ 0910–0824 9/30/2019
Abbreviated New Animal Drug Applications ............................................................................................................ 0910–0669 10/31/2019
Abbreviated New Drug Applications and 505(b)(2) Applications ............................................................................ 0910–0786 11/30/2019
Dated: December 13, 2016. Dated: December 13, 2016. DEPARTMENT OF HEALTH AND
Leslie Kux, Natasha M. Copeland, HUMAN SERVICES
Associate Commissioner for Policy. Program Analyst, Office of Federal Advisory
[FR Doc. 2016–30351 Filed 12–16–16; 8:45 am] Committee Policy. National Institutes of Health
BILLING CODE 4164–01–P [FR Doc. 2016–30360 Filed 12–16–16; 8:45 am]
National Institute of Diabetes and
BILLING CODE 4140–01–P
Digestive and Kidney Diseases; Notice
of Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the
HUMAN SERVICES Federal Advisory Committee Act, as
National Institutes of Health amended (5 U.S.C. App.), notice is
National Institutes of Health hereby given of the following meeting.
National Institute Of Allergy And
Infectious Diseases; Notice of Closed Office of the Director; Notice of Charter The meeting will be closed to the
Meeting Renewal public in accordance with the
provisions set forth in sections
Pursuant to section 10(d) of the In accordance with Title 41 of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Federal Advisory Committee Act, as U.S. Code of Federal Regulations, as amended. The contract proposals and
amended (5 U.S.C. App.), notice is Section 102–3.65(a), notice is hereby the discussions could disclose
hereby given of the following meeting. given that the Charter for the National confidential trade secrets or commercial
Toxicology Program Board of Scientific property such as patentable material,
The meeting will be closed to the and personal information concerning
public in accordance with the Counselors was renewed for an
additional two-year period on individuals associated with the contract
provisions set forth in sections proposals, the disclosure of which
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., November 14, 2016.
would constitute a clearly unwarranted
as amended. The contract proposals and It is determined that the National invasion of personal privacy.
the discussions could disclose Toxicology Program Board of Scientific
Counselors is in the public interest in Name of Committee: National Institute of
confidential trade secrets or commercial
Diabetes and Digestive and Kidney Diseases
property such as patentable material, connection with the performance of
Special Emphasis Panel; Repository Contract
and personal information concerning duties imposed on the National Review.
individuals associated with the contract Toxicology Program by law, and that Date: January 5, 2017.
proposals, the disclosure of which these duties can best be performed Time: 10:30 a.m. to 1:45 p.m.
would constitute a clearly unwarranted through the advice and counsel of this Agenda: To review and evaluate contract
invasion of personal privacy. group. proposals.
Name of Committee: National Institute of Inquiries may be directed to Jennifer Place: National Institutes of Health, Two
Allergy and Infectious Diseases Special Spaeth, Director, Office of Federal Democracy Plaza, 6707 Democracy
Emphasis Panel NIAID Peer Review Meeting. Advisory Committee Policy, Office of Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Date: January 9, 2017. the Director, National Institutes of
Time: 11:00 a.m. to 4:00 p.m. Contact Person: Michele L. Barnard, Ph.D.,
Health, 6701 Democracy Boulevard,
Agenda: To review and evaluate contract Scientific Review Officer, Review Branch,
Suite 1000, Bethesda, Maryland 20892 DEA, NIDDK, National Institutes of Health,
proposals. (Mail code 4875), Telephone (301) 496– Room 7353, 6707 Democracy Boulevard,
Place: National Institutes of Health, 5601 2123, or spaethj@od.nih.gov. Bethesda, MD 20892–2542, (301) 594–8898,
Fishers Lane, Rockville, MD 20892
Dated: December 12, 2016. arnardm@extra.niddk.nih.gov.
(Telephone Conference Call).
Contact Person: Ann Marie M. Cruz, Ph.D., Jennifer Spaeth, (Catalogue of Federal Domestic Assistance
Scientific Review Officer, Program Director, Office of Federal Advisory Program Nos. 93.847, Diabetes,
Management & Operations Branch DEA/SRP Committee Policy. Endocrinology and Metabolic Research;
RM 3E71, National Institutes of Health, 93.848, Digestive Diseases and Nutrition
[FR Doc. 2016–30364 Filed 12–16–16; 8:45 am]
NIAID, 5601 Fishers Lane, Rockville, MD Research; 93.849, Kidney Diseases, Urology
BILLING CODE 4140–01–P and Hematology Research, National Institutes
20852, 301–761–3100, AnnMarie.Cruz@
sradovich on DSK3GMQ082PROD with NOTICES
niaid.nih.gov. of Health, HHS)
(Catalogue of Federal Domestic Assistance Dated: December 13, 2016.
Program Nos. 93.855, Allergy, Immunology, David Clary,
and Transplantation Research; 93.856, Program Analyst, Office of Federal Advisory
Microbiology and Infectious Diseases Committee Policy.
Research, National Institutes of Health, HHS) [FR Doc. 2016–30363 Filed 12–16–16; 8:45 am]
BILLING CODE 4140–01–P
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Document Created: 2016-12-17 03:15:06
Document Modified: 2016-12-17 03:15:06
| 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, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 91939 |
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