Request for Nominations on the National Mammography Quality Assurance Advisory Committee, 6199-6200 [2018-02922]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices 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 FARYDAK (panobinostat). FARYDAK, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Subsequent to this approval, the USPTO received patent term restoration applications for FARYDAK (U.S. Patent Nos. 6,552,065; 6,833,384; and 7,067,551) from Novartis AG, and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated October 15, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 approval of FARYDAK 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 FARYDAK is 4,334 days. Of this time, 3,997 days occurred during the testing phase of the regulatory review period, while 337 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 15, 2003. The applicant claims April 15, 2002, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was April 15, 2003, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 24, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for FARYDAK (NDA 205353) was initially submitted on March 24, 2014. 3. The date the application was approved: February 23, 2015. FDA has verified the applicant’s claim that NDA 205353 was approved on February 23, 2015. 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 applications for patent extension, this applicant seeks 1,751 days or 5 years 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 § 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 § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 6199 investigation, and must certify that a true and complete copy of the petition 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 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02868 Filed 2–12–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0417] Request for Nominations on the National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the National Mammography Quality Assurance Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice. SUMMARY: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by March 15, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 15, 2018. DATES: E:\FR\FM\13FEN1.SGM 13FEN1 6200 Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for a nonvoting industry representative should be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301–796–5960, Fax: 301– 847–8505, email: margaret.ames@ fda.hhs.gov. The Agency is requesting nominations for a nonvoting industry representative on the National Mammography Quality Assurance Advisory Committee: SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES I. General Description of the Committee Duties The Committee shall advise FDA on: (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in these areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. VerDate Sep<11>2014 23:12 Feb 12, 2018 Jkt 244001 II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with ´ ´ their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. III. Nomination Procedure Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations must include a current, complete ´ ´ resume or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.) FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for a nonvoting representative of industry interests are encouraged from the mammography manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: February 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02922 Filed 2–12–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0002] Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document erroneously included abbreviated new drug application (ANDA) 075726 for Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error. SUMMARY: FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993–0002, 301– 796–3601. In the Federal Register of Tuesday, October 4, 2016, appearing on page 68427 in FR Doc. 2016–23893, the following correction is made: 1. On page 68430, in table 1, the entry for ANDA 075726 is removed. In a separate notice published in this issue of the Federal Register, FDA is withdrawing the approval of ANDA 075726 under 21 CFR 314.150(d). SUPPLEMENTARY INFORMATION: Dated: February 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–02926 Filed 2–12–18; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6199-6200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02922]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0417]


Request for Nominations on the National Mammography Quality 
Assurance Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to serve on the National Mammography 
Quality Assurance Advisory Committee in the Center for Devices and 
Radiological Health notify FDA in writing. FDA is also requesting 
nominations for a nonvoting industry representative to serve on the 
National Mammography Quality Assurance Advisory Committee. A nominee 
may either be self-nominated or nominated by an organization to serve 
as a nonvoting industry representative. Nominations will be accepted 
for an upcoming vacancy effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by March 15, 
2018 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by March 15, 2018.

[[Page 6200]]


ADDRESSES: All statements of interest from industry organizations 
interested in participating in the selection process of nonvoting 
industry representative nomination should be sent to Margaret Ames (see 
FOR FURTHER INFORMATION CONTACT). All nominations for a nonvoting 
industry representative should be submitted electronically by accessing 
the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail 
to Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver 
Spring, MD 20993-0002. Information about becoming a member of an FDA 
advisory committee can also be obtained by visiting FDA's website at 
https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Division of Workforce 
Management, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver 
Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: 
[email protected].

SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for a 
nonvoting industry representative on the National Mammography Quality 
Assurance Advisory Committee:

I. General Description of the Committee Duties

    The Committee shall advise FDA on: (1) Developing appropriate 
quality standards and regulations for mammography facilities; (2) 
developing appropriate standards and regulations for bodies accrediting 
mammography facilities under this program; (3) developing regulations 
with respect to sanctions; (4) developing procedures for monitoring 
compliance with standards; (5) establishing a mechanism to investigate 
consumer complaints; (6) reporting new developments concerning breast 
imaging that should be considered in the oversight of mammography 
facilities; (7) determining whether there exists a shortage of 
mammography facilities in rural and health professional shortage areas 
and determining the effects of personnel on access to the services of 
such facilities in these areas; (8) determining whether there will 
exist a sufficient number of medical physicists after October 1, 1999; 
and (9) determining the costs and benefits of compliance with these 
requirements.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations; and a list of all nominees 
along with their current r[eacute]sum[eacute]s. The letter will also 
state that it is the responsibility of the interested organizations to 
confer with one another and to select a candidate, within 60 days after 
the receipt of the FDA letter, to serve as the nonvoting member to 
represent industry interests for the committee. The interested 
organizations are not bound by the list of nominees in selecting a 
candidate. However, if no individual is selected within 60 days, the 
Commissioner will select the nonvoting member to represent industry 
interests.

III. Nomination Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Nominations must include a current, complete 
r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed 
copy of the Acknowledgement and Consent form available at the FDA 
Advisory Nomination Portal (see ADDRESSES). Nominations must also 
specify the advisory committee for which the nominee is recommended. 
Nominations must also acknowledge that the nominee is aware of the 
nomination unless self-nominated. FDA will forward all nominations to 
the organizations expressing interest in participating in the selection 
process for the committee. (Persons who nominate themselves as 
nonvoting industry representatives will not participate in the 
selection process.)
    FDA seeks to include the views of women and men, members of all 
racial and ethnic groups, and individuals with and without disabilities 
on its advisory committees and therefore encourages nominations of 
appropriately qualified candidates from these groups. Specifically, in 
this document, nominations for a nonvoting representative of industry 
interests are encouraged from the mammography manufacturing industry.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: February 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02922 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P

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