Meeting of the Advisory Committee on Organ Transplantation, 13661-13662 [2020-04744]

Download as PDF Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0601] Mylan Institutional LLC et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is SUMMARY: Application No. Drug ANDA 040471 .. Promethazine Hydrochloride (HCl) Injection, 25 milligrams (mg)/milliliters (mL). Penicillin G Procaine Injection, 300,000 units/mL and 600,000 units/mL. Cefazolin Sodium for Injection, Equivalent to (EQ) 10 grams base/vial. Azithromycin Oral Suspension, EQ 100 mg base/5 mL; EQ 200 mg base/5 mL. Dimethyl Sulfoxide Intravesical Solution, 50% ......................... Milrinone Lactate Injection, EQ 1 mg base/mL ........................ Mesna Injection, 100 mg/mL ..................................................... Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 mg ...... Stavudine Capsules, 15 mg, 20 mg, 30 mg, and 40 mg ......... ANDA 060286 .. ANDA 065247 .. ANDA 065488 .. ANDA ANDA ANDA ANDA ANDA 076185 076428 076488 078410 078957 .. .. .. .. .. ANDA 090441 .. ANDA 200563 .. ANDA 205657 .. ANDA 205658 .. ANDA 200624 .. ANDA 202384 .. ANDA 202532 .. jbell on DSKJLSW7X2PROD with NOTICES withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of April 8, 2020. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. VerDate Sep<11>2014 17:47 Mar 06, 2020 Jkt 250001 Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. Pfizer, Inc., 235 East 42nd St., New York, NY 10017. Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. Mylan Institutional LLC. Do. Do. Lupin Pharmaceuticals, Inc. Hetero USA, Inc., 1035 Centennial Ave., Piscataway, NJ 08854. Lupin Pharmaceuticals, Inc. Do. Mayne Pharma Inc., 1240 Sugg Pkwy., Greenville, NC 27834. Do. Lupin Pharmaceuticals, Inc. Do. Do. Dated: March 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04691 Filed 3–6–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Organ Transplantation Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary’s SUMMARY: PO 00000 The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Applicant Imipramine HCl Tablets, 10 mg, 25 mg, and 50 mg ................ Ciprofloxacin Oral Suspension, 250 mg/5 mL and 500 mg/5 mL. Chlorpheniramine Maleate, Hydrocodone Bitartrate, and Pseudoephedrine HCl Solution, 4 mg/5 mL; 5 mg/5 mL; and 60 mg/5 mL. Hydrocodone Bitartrate and Pseudoephedrine HCl Oral Solution, 5 mg/5 mL; and 60 mg/5 mL. Metformin HCl, and Repaglinide Tablets, 500 mg/1 mg; 500 mg/2 mg. Omeprazole Delayed-Release Capsules, 40 mg ..................... Clarithromycin Extended-Release Tablets, 500 mg ................. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 8, 2020. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on April 8, 2020 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. 13661 Frm 00040 Fmt 4703 Sfmt 4703 Advisory Committee on Organ Transplantation (ACOT) has scheduled a public meeting. Information about ACOT and the agenda for this meeting can be found on the ACOT website at https://www.organdonor.gov/about-dot/ acot.html. DATES: April 7, 2020, 8:00 a.m.–4:00 p.m. Eastern Time (ET). ADDRESSES: This meeting will be held in-person. The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857, Room 5A03. FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal Official, (DFO), at Healthcare Systems Bureau, Division of Transplantation, HRSA, 5600 Fishers Lane, 8W60, Rockville, Maryland 20857; 301–443– 6839; or RWalsh@hrsa.gov. SUPPLEMENTARY INFORMATION: ACOT provides advice and recommendations to the Secretary of HHS (Secretary) on E:\FR\FM\09MRN1.SGM 09MRN1 jbell on DSKJLSW7X2PROD with NOTICES 13662 Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices policy, program development, and other matters of significance concerning the activities under 42 U.S.C. Section 217a, Section 222 of the Public Health Service Act, as amended, and 42 CFR 121.12. ACOT advises the Secretary, through the HRSA Administrator, on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; advises the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; at the request of the Secretary, reviews significant proposed Organ Procurement and Transplantation Network policies submitted for the Secretary’s approval to recommend whether they should be made enforceable; and provides expert input on the latest advances in the science of transplantation. During the April 7, 2020, meeting, ACOT will discuss issues related to the recent HHS National Survey of Organ Donation Attitudes and Behaviors and efforts to increase organ transplantation. Agenda items are subject to change as priorities dictate. Refer to the ACOT website for any updated information concerning the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to ACOT should be sent to Robert Walsh, DFO, using the contact information above at least 3 business days prior to the meeting. Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Robert Walsh at the address and phone number listed above at least 10 business days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–04744 Filed 3–6–20; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:47 Mar 06, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Application and Other Forms Used by the National Health Service Corps (NHSC) Scholarship Program (SP), the NHSC Students to Service Loan Repayment Program (S2S LRP), and the Native Hawaiian Health Scholarship Program (NHHSP), OMB No. 0915–0146— Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than May 8, 2020. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Application and Other Forms Used by NHSC Scholarship Program (SP), the NHSC Students to Service Loan Repayment Program, and the Native Hawaiian Health Scholarship Program. SUMMARY: OMB No. 0915–0146—Revision Abstract: Administered by HRSA’s Bureau of Health Workforce, the NHSC SP, NHSC S2S LRP, and the NHHSP provide scholarships or loan repayment to qualified students who are pursuing PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 primary care health professions education and training. In return, students agree to provide primary health care services in medically underserved communities located in federally designated Health Professional Shortage Areas once they are fully trained and licensed health professionals. Awards are made to applicants who demonstrate the greatest potential for successful completion of their education and training as well as commitment to provide primary health care services to communities of greatest need. The information from program applications, forms, and supporting documentation is used to select the best qualified candidates for these competitive awards, and to monitor program participants’ enrollment in school, postgraduate training, and compliance with program requirements. Although some program forms vary from program to program (see programspecific burden charts below), required forms generally include: A program application, academic and nonacademic letters of recommendation, the authorization to release information, and the acceptance/verification of good standing report. Additional forms for the NHSC SP include the data collection worksheet, which is completed by the educational institutions of program participants; the post-graduate training verification form (applicable for NHSC S2S LRP participants), which is completed by program participants and their residency director; and the enrollment verification form, which is completed by program participants and the educational institution for each academic term. For this ICR, the NHHSP program proposes to add 3 new forms including the scholar enrollment verification, change in program curriculum and graduation documentation forms. These forms will be completed by the grantee on behalf of the participant and the educational institution to verify the participant’s enrollment status for each academic term, to provide notice of any change in the participant’s program curriculum, and to verify that NHHSP has met its financial obligation to pay tuition and related fees or to hold additional funds to cover any tuition balance or fees on the participant’s student account. Need and Proposed Use of the Information: The NHSC SP, S2S LRP, and NHHSP applications, forms, and supporting documentation are used to collect necessary information from applicants that enable HRSA to make selection determinations for the competitive awards and monitor compliance with program requirements. E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13661-13662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the Advisory Committee on Organ Transplantation

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Secretary's Advisory Committee on Organ 
Transplantation (ACOT) has scheduled a public meeting. Information 
about ACOT and the agenda for this meeting can be found on the ACOT 
website at https://www.organdonor.gov/about-dot/acot.html.

DATES: April 7, 2020, 8:00 a.m.-4:00 p.m. Eastern Time (ET).

ADDRESSES: This meeting will be held in-person. The address for the 
meeting is 5600 Fishers Lane, Rockville, Maryland 20857, Room 5A03.

FOR FURTHER INFORMATION CONTACT: Robert Walsh, Designated Federal 
Official, (DFO), at Healthcare Systems Bureau, Division of 
Transplantation, HRSA, 5600 Fishers Lane, 8W60, Rockville, Maryland 
20857; 301-443-6839; or [email protected].

SUPPLEMENTARY INFORMATION: ACOT provides advice and recommendations to 
the Secretary of HHS (Secretary) on

[[Page 13662]]

policy, program development, and other matters of significance 
concerning the activities under 42 U.S.C. Section 217a, Section 222 of 
the Public Health Service Act, as amended, and 42 CFR 121.12. ACOT 
advises the Secretary, through the HRSA Administrator, on all aspects 
of organ donation, procurement, allocation, and transplantation, and on 
such other matters that the Secretary determines; advises the Secretary 
on federal efforts to maximize the number of deceased donor organs made 
available for transplantation and to support the safety of living organ 
donation; at the request of the Secretary, reviews significant proposed 
Organ Procurement and Transplantation Network policies submitted for 
the Secretary's approval to recommend whether they should be made 
enforceable; and provides expert input on the latest advances in the 
science of transplantation.
    During the April 7, 2020, meeting, ACOT will discuss issues related 
to the recent HHS National Survey of Organ Donation Attitudes and 
Behaviors and efforts to increase organ transplantation. Agenda items 
are subject to change as priorities dictate. Refer to the ACOT website 
for any updated information concerning the meeting.
    Members of the public will have the opportunity to provide 
comments. Public participants may submit written statements in advance 
of the scheduled meeting. Oral comments will be honored in the order 
they are requested and may be limited as time allows. Requests to 
submit a written statement or make oral comments to ACOT should be sent 
to Robert Walsh, DFO, using the contact information above at least 3 
business days prior to the meeting.
    Individuals who plan to attend and need special assistance or 
another reasonable accommodation should notify Robert Walsh at the 
address and phone number listed above at least 10 business days prior 
to the meeting. Since this meeting occurs in a federal government 
building, attendees must go through a security check to enter the 
building. Non-U.S. Citizen attendees must notify HRSA of their planned 
attendance at least 20 business days prior to the meeting in order to 
facilitate their entry into the building. All attendees are required to 
present government-issued identification prior to entry.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-04744 Filed 3-6-20; 8:45 am]
 BILLING CODE 4165-15-P

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