81 FR 95620 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 249 (December 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 249 (December 28, 2016)
| Page Range | 95620-95620 | |
| FR Document | 2016-31391 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Notices] [Page 95620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31391] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration is correcting a notice entitled ``Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting'' that appeared in the Federal Register of November 29, 2016 (81 FR 85978). The document announced the forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The document was published with an error in the DATES section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, November 29, 2016, in FR Doc. 2016-28723, the following correction is made: On page 85978, in the third column, in the DATES section, the following sentence is to be inserted after the first sentence: ``FDA is opening a docket for public comment on this meeting. The docket number is FDA-2010-N-0067. The docket will open for public comment on December 28, 2016. The docket will close on April 14, 2017.'' Dated: December 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-31391 Filed 12-27-16; 8:45 am] BILLING CODE 4164-01-P
![95620 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
phase of the regulatory review period, DEPARTMENT OF HEALTH AND Dated: December 22, 2016.
while 457 days occurred during the HUMAN SERVICES Leslie Kux,
approval phase. These periods of time Associate Commissioner for Policy.
were derived from the following dates: Food and Drug Administration [FR Doc. 2016–31391 Filed 12–27–16; 8:45 am]
1. The date an exemption under BILLING CODE 4164–01–P
section 505(i) of the Federal Food, Drug, [Docket No. FDA–2010–N–0067]
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2005. FDA Pharmaceutical Science and Clinical DEPARTMENT OF HEALTH AND
has verified the applicant’s claim that Pharmacology Advisory Committee; HUMAN SERVICES
the date the investigational new drug Notice of Meeting; Correction
application became effective was on Health Resources and Services
May 25, 2005. AGENCY: Food and Drug Administration, Administration
HHS.
2. The date the application was
ACTION: Notice; correction. Agency Information Collection
initially submitted with respect to the
Activities: Submission to OMB for
human biological product under section
SUMMARY: The Food and Drug Review and Approval; Public Comment
351 of the Public Health Service Act (42
Administration is correcting a notice Request; Evaluation and Assessment
U.S.C. 262): July 28, 2014. FDA has
entitled ‘‘Pharmaceutical Science and of HRSA Teaching Health Centers
verified the applicant’s claim that the
biologics license application (BLA) for Clinical Pharmacology Advisory AGENCY: Health Resources and Services
IMLYGIC (BLA 125518) was initially Committee; Notice of Meeting’’ that Administration (HRSA), Department of
submitted on July 28, 2014. appeared in the Federal Register of Health and Human Services (HHS).
3. The date the application was November 29, 2016 (81 FR 85978). The
ACTION: Notice.
approved: October 27, 2015. FDA has document announced the forthcoming
verified the applicant’s claim that BLA public advisory committee meeting of SUMMARY: In compliance with Section
125518 was approved on October 27, the Pharmaceutical Science and Clinical 3507(a)(1)(D) of the Paperwork
2015. Pharmacology Advisory Committee. The Reduction Act of 1995, HRSA has
This determination of the regulatory document was published with an error submitted an Information Collection
review period establishes the maximum in the DATES section. This document Request (ICR) to the Office of
potential length of a patent extension. corrects that error. Management and Budget (OMB) for
However, the USPTO applies several FOR FURTHER INFORMATION CONTACT: review and approval. Comments
statutory limitations in its calculations Jennifer Shepherd, Center for Drug submitted during the first public review
of the actual period for patent extension. Evaluation and Research, Food and of this ICR will be provided to OMB.
In its applications for patent extension, Drug Administration, 10903 New OMB will accept further comments from
this applicant seeks 1,826 days, 1,764 Hampshire Ave., Bldg. 31, Rm. 2417, the public during the review and
days, or 1400 days, respectively, of Silver Spring, MD 20993–0002, 301– approval period.
patent term extension. 796–9001, FAX: 301–847–8533, email: DATES: Comments on this ICR should be
ACPS-CP@fda.hhs.gov, or FDA received no later than January 27, 2017.
III. Petitions Advisory Committee Information Line, ADDRESSES: Submit your comments,
Anyone with knowledge that any of 1–800–741–8138 (301–443–0572 in the including the ICR Title, to the desk
the dates as published are incorrect may Washington, DC area). A notice in the officer for HRSA, either by email to
submit either electronic or written Federal Register about last minute OIRA_submission@omb.eop.gov or by
comments and ask for a redetermination modifications that impact a previously fax to 202–395–5806.
(see DATES). Furthermore, any interested announced advisory committee meeting
cannot always be published quickly FOR FURTHER INFORMATION CONTACT: To
person may petition FDA for a
determination regarding whether the enough to provide timely notice. request a copy of the clearance requests
applicant for extension acted with due Therefore, you should always check the submitted to OMB for review, email the
diligence during the regulatory review Agency’s Web site at http:// HRSA Information Collection Clearance
period. To meet its burden, the petition www.fda.gov/AdvisoryCommittees/ Officer at paperwork@hrsa.gov or call
must be timely (see DATES) and contain default.htm and scroll down to the (301) 443–1984.
sufficient facts to merit an FDA appropriate advisory committee meeting SUPPLEMENTARY INFORMATION:
investigation. (See H. Rept. 857, part 1, link, or call the advisory committee Information Collection Request Title:
98th Cong., 2d sess., pp. 41–42, 1984.) information line to learn about possible Evaluation and Assessment of HRSA
Petitions should be in the format modifications before coming to the Teaching Health Centers.
specified in 21 CFR 10.30. meeting. OMB No. 0915–0376—Extension.
Submit petitions electronically to Abstract: The Teaching Health Center
SUPPLEMENTARY INFORMATION: Graduate Medical Education (THCGME)
https://www.regulations.gov at Docket
In the Federal Register of Tuesday, program supports new and the
No. FDA–2013–S–0610. Submit written
November 29, 2016, in FR Doc. 2016– expansion of existing primary care
petitions (two copies are required) to the
28723, the following correction is made: residency training programs in
Division of Dockets Management (HFA–
305), Food and Drug Administration, On page 85978, in the third column, community-based settings. The primary
in the DATES section, the following goals of the THCGME program are to
sradovich on DSK3GMQ082PROD with NOTICES
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. sentence is to be inserted after the first increase the production of primary care
sentence: ‘‘FDA is opening a docket for doctors and dentists who are well
Dated: December 21, 2016. public comment on this meeting. The prepared to practice in community
Leslie Kux, docket number is FDA–2010–N–0067. settings, particularly with underserved
Associate Commissioner for Policy. The docket will open for public populations, and to improve the overall
[FR Doc. 2016–31322 Filed 12–27–16; 8:45 am] comment on December 28, 2016. The number and geographic distribution of
BILLING CODE 4164–01–P docket will close on April 14, 2017.’’ primary care providers.
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Document Created: 2016-12-28 02:16:55
Document Modified: 2016-12-28 02:16:55
| 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; correction. | |
| Contact | Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 81 FR 95620 |
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