83_FR_7783 83 FR 7747 - Determination of Regulatory Review Period for Purposes of Patent Extension; OFEV

83 FR 7747 - Determination of Regulatory Review Period for Purposes of Patent Extension; OFEV

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range7747-7749
FR Document2018-03606

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OFEV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Federal Register, Volume 83 Issue 36 (Thursday, February 22, 2018) 
[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7747-7749]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-E-4020]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; OFEV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has 
determined the regulatory review period for OFEV and is publishing this 
notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of the U.S. Patent and Trademark Office (USPTO), Department of 
Commerce, for the extension of a patent which claims that human drug 
product.

DATES: Anyone with knowledge that any of the dates as published (in the 
SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by April 
23, 2018. Late, untimely filed comments will not be considered. 
Electronic comments must be submitted on or before April 23, 2018. The 
https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of April 23, 2018. 
Comments received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date. 
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 by August 21, 2018. See 
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 7748]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-E-4020 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; OFEV.'' Received comments, those filed in 
a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and 
other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term 
Restoration Act (Pub. L. 100-670) generally provide that a patent may 
be extended for a period of up to 5 years so long as the patented item 
(human drug product, animal drug product, medical device, food 
additive, or color additive) was subject to regulatory review by FDA 
before the item was marketed. Under these acts, a product's regulatory 
review period forms the basis for determining the amount of extension 
an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the drug becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human drug product and 
continues until FDA grants permission to market the drug 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 
drug 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 drug product OFEV 
(nintedanib esylate). OFEV is indicated for treatment of idiopathic 
pulmonary fibrosis. Subsequent to this approval, the USPTO received a 
patent term restoration application for OFEV (U.S. Patent No. 
6,762,180) from Boehringer Ingelheim Pharma Gmbh & Co. KG, and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated December 17, 
2015, FDA advised the USPTO that this human drug product had undergone 
a regulatory review period and that the approval of OFEV 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 
OFEV is 3,480 days. Of this time, 3,313 days occurred during the 
testing phase of the regulatory review period, while 167 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 (the FD&C Act) (21 U.S.C. 355(i)) became 
effective: April 7, 2005. The applicant claims April 8, 2005, as the 
date the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was April 7, 
2005, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: May 2, 
2014. FDA has verified the applicant's claim that the new drug 
application (NDA) for OFEV (NDA 205832) was initially submitted on May 
2, 2014.
    3. The date the application was approved: October 15, 2014. FDA has 
verified the applicant's claim that NDA 205832 was approved on October 
15, 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 1,822 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, under 
21 CFR 60.24 ask for a redetermination (see DATES). Furthermore, as 
specified in Sec.  60.30 (21 CFR 60.30), 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 comply with all the requirements 
of Sec.  60.30, including but not limited to: must be timely (see 
DATES), must be filed in accordance with Sec.  10.20, must contain 
sufficient facts to merit an FDA investigation, and must certify that a 
true and complete copy of the petition

[[Page 7749]]

has been served upon the patent applicant. (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 Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03606 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7747 803 (21 CFR part 803)). The reporting of recommends that manufacturers of these reasonably known to the manufacturer adverse device events summarized in an devices file with FDA an annual report and evaluating the cause of the event annual report will alert FDA to trends for 3 consecutive years, this would be (§ 803.50(b) (21 CFR 803.50(b)). In or clusters of events that might be a less burdensome than the current addition, manufacturers of medical safety issue otherwise unreported under postapproval requirements under 21 devices are required to submit to FDA the MDR regulation. The report should CFR part 814, subpart E, including the individual adverse event reports of also include any subsequent change to submission of periodic reports under 21 death, serious injury, and malfunctions the preamendments class III device CFR 814.84. (§ 803.50). requiring a 30-day notice in accordance Collecting or transfusing facilities, the with 21 CFR 814.39(f). intended users of the device, and the In the special control guidance Reclassification of this device from device manufacturers have certain document, FDA recommends that class III to class II relieves responsibilities under the Federal manufacturers include in their three manufacturers of the burden of regulations. For example, collecting or annual reports a summary of adverse complying with the premarket approval transfusing facilities are required to reactions maintained by the collecting requirements of section 515 of the FD&C maintain records of any reports of or transfusing facility or similar reports Act (21 U.S.C. 360e) and may permit complaints of adverse reactions (21 CFR of adverse events collected. small potential competitors to enter the 606.170), while the device manufacturer FDA estimates the burden of this marketplace by reducing the burden. is responsible for conducting an collection of information as follows: Although the special control guidance investigation of each event that is TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Reporting activity responses per burden per Total hours respondents responses respondent response Annual Report ...................................................................... 3 1 3 5 15 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA records, there are determined the regulatory review period Electronic Submissions approximately three manufacturers of for OFEV and is publishing this notice automated blood cell separator devices. of that determination as required by Submit electronic comments in the We estimate that the manufacturers will law. FDA has made the determination following way: spend approximately 5 hours preparing because of the submission of an • Federal eRulemaking Portal: and submitting the annual report. The application to the Director of the U.S. https://www.regulations.gov. Follow the total burden hours are reduced from Patent and Trademark Office (USPTO), instructions for submitting comments. previous collections due to a decrease in Department of Commerce, for the Comments submitted electronically, the number of manufacturers. extension of a patent which claims that including attachments, to https:// Other burden hours required for human drug product. www.regulations.gov will be posted to § 864.9245 are reported and approved DATES: Anyone with knowledge that any the docket unchanged. Because your under OMB control number 0910–0120 of the dates as published (in the comment will be made public, you are (premarket notification submission SUPPLEMENTARY INFORMATION section) are solely responsible for ensuring that your 510(k), 21 CFR part 807, subpart E), and incorrect may submit either electronic comment does not include any OMB control number 0910–0437 (MDR, or written comments and ask for a confidential information that you or a part 803). redetermination by April 23, 2018. Late, third party may not wish to be posted, untimely filed comments will not be such as medical information, your or Dated: February 15, 2018. considered. Electronic comments must anyone else’s Social Security number, or Leslie Kux, confidential business information, such be submitted on or before April 23, Associate Commissioner for Policy. as a manufacturing process. Please note 2018. The https://www.regulations.gov [FR Doc. 2018–03613 Filed 2–21–18; 8:45 am] electronic filing system will accept that if you include your name, contact BILLING CODE 4164–01–P comments until midnight Eastern Time information, or other information that at the end of April 23, 2018. Comments identifies you in the body of your received by mail/hand delivery/courier comments, that information will be DEPARTMENT OF HEALTH AND (for written/paper submissions) will be posted on https://www.regulations.gov. HUMAN SERVICES considered timely if they are • If you want to submit a comment postmarked or the delivery service with confidential information that you Food and Drug Administration acceptance receipt is on or before that do not wish to be made available to the [Docket No. FDA–2015–E–4020] date. Furthermore, any interested public, submit the comment as a person may petition FDA for a written/paper submission and in the Determination of Regulatory Review determination regarding whether the manner detailed (see ‘‘Written/Paper Period for Purposes of Patent applicant for extension acted with due Submissions’’ and ‘‘Instructions’’). daltland on DSKBBV9HB2PROD with NOTICES Extension; OFEV diligence during the regulatory review period by August 21, 2018. See Written/Paper Submissions AGENCY: Food and Drug Administration, HHS. ‘‘Petitions’’ in the SUPPLEMENTARY Submit written/paper submissions as INFORMATION section for more follows: ACTION: Notice. information. • Mail/Hand delivery/Courier (for SUMMARY: The Food and Drug ADDRESSES: You may submit comments written/paper submissions): Dockets Administration (FDA or the Agency) has as follows: Management Staff (HFA–305), Food and VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

7748 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, commercial marketing or use of the Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. product. Thereafter, the USPTO • For written/paper comments FOR FURTHER INFORMATION CONTACT: requested that FDA determine the submitted to the Dockets Management Beverly Friedman, Office of Regulatory product’s regulatory review period. Staff, FDA will post your comment, as Policy, Food and Drug Administration, well as any attachments, except for II. Determination of Regulatory Review 10903 New Hampshire Ave., Bldg. 51, Period information submitted, marked and Rm. 6250, Silver Spring, MD 20993, identified, as confidential, if submitted 301–796–3600. FDA has determined that the as detailed in ‘‘Instructions.’’ applicable regulatory review period for SUPPLEMENTARY INFORMATION: Instructions: All submissions received OFEV is 3,480 days. Of this time, 3,313 must include the Docket No. FDA– I. Background days occurred during the testing phase 2015–E–4020 for ‘‘Determination of of the regulatory review period, while The Drug Price Competition and Regulatory Review Period for Purposes 167 days occurred during the approval Patent Term Restoration Act of 1984 of Patent Extension; OFEV.’’ Received phase. These periods of time were (Pub. L. 98–417) and the Generic comments, those filed in a timely derived from the following dates: Animal Drug and Patent Term 1. The date an exemption under manner (see ADDRESSES), will be placed Restoration Act (Pub. L. 100–670) section 505(i) of the Federal Food, Drug, in the docket and, except for those generally provide that a patent may be and Cosmetic Act (the FD&C Act) (21 submitted as ‘‘Confidential Submissions,’’ publicly viewable at extended for a period of up to 5 years U.S.C. 355(i)) became effective: April 7, https://www.regulations.gov or at the so long as the patented item (human 2005. The applicant claims April 8, Dockets Management Staff between 9 drug product, animal drug product, 2005, as the date the investigational new a.m. and 4 p.m., Monday through medical device, food additive, or color drug application (IND) became effective. Friday. additive) was subject to regulatory However, FDA records indicate that the • Confidential Submissions—To review by FDA before the item was IND effective date was April 7, 2005, submit a comment with confidential marketed. Under these acts, a product’s which was 30 days after FDA receipt of information that you do not wish to be regulatory review period forms the basis the IND. made publicly available, submit your for determining the amount of extension 2. The date the application was comments only as a written/paper an applicant may receive. initially submitted with respect to the submission. You should submit two A regulatory review period consists of human drug product under section copies total. One copy will include the two periods of time: A testing phase and 505(b) of the FD&C Act: May 2, 2014. information you claim to be confidential an approval phase. For human drug FDA has verified the applicant’s claim with a heading or cover note that states products, the testing phase begins when that the new drug application (NDA) for ‘‘THIS DOCUMENT CONTAINS the exemption to permit the clinical OFEV (NDA 205832) was initially CONFIDENTIAL INFORMATION.’’ The investigations of the drug becomes submitted on May 2, 2014. Agency will review this copy, including effective and runs until the approval 3. The date the application was the claimed confidential information, in phase begins. The approval phase starts approved: October 15, 2014. FDA has its consideration of comments. The with the initial submission of an verified the applicant’s claim that NDA second copy, which will have the application to market the human drug 205832 was approved on October 15, claimed confidential information product and continues until FDA grants 2014. redacted/blacked out, will be available permission to market the drug product. This determination of the regulatory for public viewing and posted on Although only a portion of a regulatory review period establishes the maximum https://www.regulations.gov. Submit review period may count toward the potential length of a patent extension. both copies to the Dockets Management actual amount of extension that the However, the USPTO applies several Staff. If you do not wish your name and Director of USPTO may award (for statutory limitations in its calculations contact information to be made publicly example, half the testing phase must be of the actual period for patent extension. available, you can provide this subtracted as well as any time that may In its application for patent extension, information on the cover sheet and not have occurred before the patent was this applicant seeks 1,822 days of patent in the body of your comments and you issued), FDA’s determination of the term extension. must identify this information as length of a regulatory review period for ‘‘confidential.’’ Any information marked a human drug product will include all III. Petitions as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase Anyone with knowledge that any of except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may CFR 10.20) and other applicable FDA has approved for marketing the submit either electronic or written disclosure law. For more information human drug product OFEV (nintedanib comments and, under 21 CFR 60.24 ask about FDA’s posting of comments to esylate). OFEV is indicated for treatment for a redetermination (see DATES). public dockets, see 80 FR 56469, of idiopathic pulmonary fibrosis. Furthermore, as specified in § 60.30 (21 September 18, 2015, or access the Subsequent to this approval, the USPTO CFR 60.30), any interested person may information at: https://www.gpo.gov/ received a patent term restoration petition FDA for a determination fdsys/pkg/FR-2015-09-18/pdf/2015- application for OFEV (U.S. Patent No. regarding whether the applicant for 23389.pdf. 6,762,180) from Boehringer Ingelheim extension acted with due diligence Docket: For access to the docket to Pharma Gmbh & Co. KG, and the during the regulatory review period. To read background documents or the USPTO requested FDA’s assistance in meet its burden, the petition must daltland on DSKBBV9HB2PROD with NOTICES electronic and written/paper comments determining this patent’s eligibility for comply with all the requirements of received, go to https:// patent term restoration. In a letter dated § 60.30, including but not limited to: www.regulations.gov and insert the December 17, 2015, FDA advised the must be timely (see DATES), must be docket number, found in brackets in the USPTO that this human drug product filed in accordance with § 10.20, must heading of this document, into the had undergone a regulatory review contain sufficient facts to merit an FDA ‘‘Search’’ box and follow the prompts period and that the approval of OFEV investigation, and must certify that a and/or go to the Dockets Management represented the first permitted true and complete copy of the petition VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1

Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices 7749 has been served upon the patent 93.846-93.878, 93.892, 93.893, National Closed: 12:10 p.m. to 2:20 p.m. applicant. (See H. Rept. 857, part 1, 98th Institutes of Health, HHS) Agenda: To review and evaluate personal Cong., 2d sess., pp. 41–42, 1984.) Dated: February 16, 2018. qualifications and performance, and competence of individual investigators. Petitions should be in the format Melanie J. Pantoja, Place: National Institute on Aging, specified in 21 CFR 10.30. Program Analyst, Office of Federal Advisory Biomedical Research Center, 3rd Floor Submit petitions electronically to Committee Policy. Conference Room 03C227, 251 Bayview https://www.regulations.gov at Docket [FR Doc. 2018–03666 Filed 2–21–18; 8:45 am] Boulevard, Baltimore, MD 21224. No. FDA–2013–S–0610. Submit written BILLING CODE 4140–01–P Closed: 2:20 p.m. to 3:45 p.m. petitions (two copies are required) to the Agenda: To review and evaluate personal Dockets Management Staff (HFA–305), qualifications and performance, and Food and Drug Administration, 5630 DEPARTMENT OF HEALTH AND competence of individual investigators. Fishers Lane, Rm. 1061, Rockville, MD HUMAN SERVICES Place: National Institute on Aging, 20852. Biomedical Research Center, 3rd Floor National Institutes of Health Conference Room 03C227, 251 Bayview Dated: February 15, 2018. Boulevard, Baltimore, MD 21224. Leslie Kux, National Institute on Aging; Notice of Closed: 3:45 p.m. to 5:20 p.m. Associate Commissioner for Policy. Meeting Agenda: To review and evaluate personal [FR Doc. 2018–03606 Filed 2–21–18; 8:45 am] qualifications and performance, and Pursuant to section 10(d) of the competence of individual investigators. BILLING CODE 4164–01–P Federal Advisory Committee Act, as Place: National Institute on Aging, amended, notice is hereby given of a Biomedical Research Center, 3rd Floor meeting of the Board of Scientific Conference Room 03C227, 251 Bayview DEPARTMENT OF HEALTH AND Boulevard, Baltimore, MD 21224. HUMAN SERVICES Counselors, NIA. The meeting will be open to the public as indicated below, Closed: 5:20 p.m. to 6:20 p.m. National Institutes of Health with attendance limited to space Agenda: To review and evaluate personal available. Individuals who plan to qualifications and performance, and Center for Scientific Review; Notice of competence of individual investigators. attend and need special assistance, such Place: National Institute on Aging, Closed Meeting as sign language interpretation or other Biomedical Research Center, 3rd Floor reasonable accommodations, should Conference Room 03C227, 251 Bayview Pursuant to section 10(d) of the notify the Contact Person listed below Boulevard, Baltimore, MD 21224. Federal Advisory Committee Act, as in advance of the meeting. amended, notice is hereby given of the Contact Person: Luigi Ferrucci, Ph.D., MD, The meeting will be closed to the Scientific Director, National Institute on following meeting. public as indicated below in accordance Aging, 251 Bayview Boulevard, Suite 100, The meeting will be closed to the with the provisions set forth in section Room 4C225, Baltimore, MD 21224, 410– public in accordance with the 552b(c)(6), Title 5 U.S.C., as amended 558–8110, LF27Z@NIH.GOV. provisions set forth in sections for the review, discussion, and (Catalogue of Federal Domestic Assistance 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., evaluation of individual intramural Program Nos. 93.866, Aging Research, as amended. The grant applications and programs and projects conducted by the National Institutes of Health, HHS) the discussions could disclose NATIONAL INSTITUTE ON AGING, Dated: February 15, 2018. confidential trade secrets or commercial including consideration of personnel Melanie J. Pantoja, property such as patentable material, qualifications and performance, and the Program Analyst, Office of Federal Advisory and personal information concerning competence of individual investigators, Committee Policy. individuals associated with the grant the disclosure of which would [FR Doc. 2018–03558 Filed 2–21–18; 8:45 am] applications,the disclosure of which constitute a clearly unwarranted would constitute a clearly unwarranted BILLING CODE 4140–01–P invasion of personal privacy. invasion of personal privacy. Name of Committee: Board of Scientific Name of Committee: Center for Scientific Counselors, NIA DEPARTMENT OF HEALTH AND Review Special Emphasis Panel; Date: April 10, 2018 HUMAN SERVICES Biochemistry and Biophysics of Biological Closed: 8:00 a.m. to 8:20 a.m. Macromolecules Fellowship Applications. Agenda: To review and evaluate personal National Institutes of Health Date: March 1, 2018. qualifications and performance, and Time: 11:00 a.m. to 4:00 p.m. competence of individual investigators. National Institute of Mental Health; Agenda: To review and evaluate grant Place: National Institute on Aging, Notice of Closed Meetings applications. Biomedical Research Center, 3rd Floor Place: National Institutes of Health, 6701 Conference Room 03C227, 251 Bayview Rockledge Drive, Bethesda, MD 20892 Pursuant to section 10(d) of the Boulevard, Baltimore, MD 21224. (Virtual Meeting). Federal Advisory Committee Act, as Open: 8:20 a.m. to 11:50 a.m. Contact Person: Mike Radtke, Ph.D., Agenda: Committee discussion, individual amended notice is hereby given of the Scientific Review Officer, Center for presentations, laboratory overview. following meetings. Scientific Review, National Institutes of Place: National Institute on Aging, The meetings will be closed to the Health, 6701 Rockledge Drive, Room 4176, Biomedical Research Center, 3rd Floor public in accordance with the MSC 7806, Bethesda, MD 20892, 301–435– Conference Room 03C227, 251 Bayview 1728, radtkem@csr.nih.gov. provisions set forth in sections Boulevard, Baltimore, MD 21224. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., daltland on DSKBBV9HB2PROD with NOTICES This notice is being published less than 15 Closed: 11:50 a.m. to 12:10 p.m. days prior to the meeting due to the timing as amended. The grant applications and Agenda: To review and evaluate personal limitations imposed by the review and the discussions could disclose qualifications and performance, and funding cycle. competence of individual investigators. confidential trade secrets or commercial (Catalogue of Federal Domestic Assistance Place: National Institute on Aging, property such as patentable material, Program Nos. 93.306, Comparative Medicine; Biomedical Research Center, 3rd Floor and personal information concerning 93.333, Clinical Research, 93.306, 93.333, Conference Room 03C227, 251 Bayview individuals associated with the grant 93.337, 93.393–93.396, 93.837–93.844, Boulevard, Baltimore, MD 21224. applications, the disclosure of which VerDate Sep<11>2014 20:10 Feb 21, 2018 Jkt 244001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\22FEN1.SGM 22FEN1


Document Created: 2018-02-22 02:50:54
Document Modified: 2018-02-22 02:50:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 23, 2018. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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 by August 21, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation83 FR 7747 
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