Request for Nominations on the National Mammography Quality Assurance Advisory Committee, 67944-67945 [2019-26735]

Download as PDF 67944 Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices khammond on DSKJM1Z7X2PROD with NOTICES the same date FDA determined was the beginning of the regulatory review period for BRIVIACT ORAL TABLETS approved under NDA 205836 and for BRIVIACT INJECTION approved under NDA 205837. The regulatory review period determinations for BRIVIACT ORAL TABLETS and BRIVIACT INJECTION are published in this issue of the Federal Register. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 20, 2014. FDA has verified the applicant’s claim that the NDA for BRIVIACT ORAL SOLUTION (NDA 205838) was initially submitted on November 20, 2014. 3. For a drug recommended for controls under the CSA, the later of the date the NDA was approved under section 505 of the FD&C Act or the date of issuance of the interim final rule controlling the drug: May 12, 2016. FDA has verified the applicant’s claim that NDA 205838 was approved on February 18, 2016. FDA has also verified that the date of issuance of the interim final rule controlling the drug, placing BRIVIACT ORAL SOLUTION (brivaracetam) in schedule V of the CSA as revised by the Improving Regulatory Transparency for New Medical Therapies Act, was May 12, 2016. 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 698 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 § 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 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. VerDate Sep<11>2014 17:56 Dec 11, 2019 Jkt 250001 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: December 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26814 Filed 12–11–19; 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 current and upcoming vacancies 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 January 13, 2020 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by January 13, 2020. 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 SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 Management Services, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993, 301–796– 5960, Fax: 301–847–8505, email: margaret.ames@fda.hhs.gov. 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 E:\FR\FM\12DEN1.SGM 12DEN1 Federal Register / Vol. 84, No. 239 / Thursday, December 12, 2019 / Notices 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 re´sume´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. khammond on DSKJM1Z7X2PROD with NOTICES 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 re´sume´ 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: December 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–26735 Filed 12–11–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:56 Dec 11, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–E–2525] Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIVIACT INJECTION 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. SUMMARY: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 10, 2020. 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 June 9, 2020. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 10, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 10, 2020. 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. DATES: 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 67945 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 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– 2016–E–2525 for Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION. 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 E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 84, Number 239 (Thursday, December 12, 2019)]
[Notices]
[Pages 67944-67945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26735]


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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.

-----------------------------------------------------------------------

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 current and upcoming vacancies 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 January 
13, 2020 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by January 13, 2020.

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 Management 
Services, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, 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

[[Page 67945]]

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: December 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26735 Filed 12-11-19; 8:45 am]
 BILLING CODE 4164-01-P

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