Determination That JADELLE (Levonorgestrel) Implant, 75 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 51575-51576 [2014-20634]

Download as PDF Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices wreier-aviles on DSK5TPTVN1PROD with NOTICES It is ACF’s policy to integrate both use of existing evidence and opportunities for further learning into all of our activities. Where an evidence base is lacking, we will build evidence through strong evaluations. Where evidence exists, we will use it. Discretionary funding opportunity announcements will require that successful applicants cooperate with any Federal evaluations if selected to participate. As legally allowed, programs with waiver authorities should require rigorous evaluations as a condition of waivers. As appropriate, ACF will encourage, incentivize, or require grantees to use existing evidence of effective strategies in designing or selecting service approaches. The emphasis on evidence is meant to support, not inhibit, innovation, improvement, and learning. Transparency: ACF will make information about planned and ongoing evaluations easily accessible, typically through posting on the web information about the contractor or grantee conducting the work and descriptions of the evaluation questions, methods to be used, and expected timeline for reporting results. ACF will present information about study designs, implementation, and findings at professional conferences. Study plans will be published in advance. ACF will release evaluation results regardless of the findings. Evaluation reports will describe the methods used, including strengths and weaknesses, and discuss the generalizability of the findings. Evaluation reports will present comprehensive results, including favorable, unfavorable, and null findings. ACF will release evaluation results timely—usually within 2 months of a report’s completion. ACF will archive evaluation data for secondary use by interested researchers, typically through building requirements into contracts to prepare data sets for secondary use. Independence: Independence and objectivity are core principles of evaluation.1 Agency and program leadership, program staff, service providers, and others should participate actively in setting evaluation priorities, identifying evaluation questions, and assessing the implications of findings. However, it is important to insulate 1American Evaluation Association, ‘‘An Evaluation Roadmap for a More Effective Government’’, November 2013, http:// www.eval.org/d/do/472, accessed 16 December 2013, and Government Accountability Office, ‘‘Employment and Training Administration: Increased Authority and Accountability Could Improve Research Program’’, GAO–10- 243, January 2010, http://www.gao.gov/products/GAO-10-243, accessed 18 June 2012. VerDate Mar<15>2010 15:25 Aug 28, 2014 Jkt 232001 evaluation functions from undue influence and from both the appearance and the reality of bias. To promote objectivity, ACF protects independence in the design, conduct, and analysis of evaluations. To this end: • ACF will conduct evaluations through the competitive award of grants and contracts to external experts who are free from conflicts of interest. • The director of OPRE reports directly to the Assistant Secretary for Children and Families; has authority to approve the design of evaluation projects and analysis plans; and has authority to approve, release, and disseminate evaluation reports. Ethics: ACF-sponsored evaluations will be conducted in an ethical manner and safeguard the dignity, rights, safety, and privacy of participants. ACFsponsored evaluations will comply with both the spirit and the letter of relevant requirements such as regulations governing research involving human subjects. Mark H. Greenberg, Acting Assistant Secretary for Children and Families. [FR Doc. 2014–20616 Filed 8–28–14; 8:45 am] BILLING CODE 4184–79–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–P–0886] Determination That JADELLE (Levonorgestrel) Implant, 75 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) has determined that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993–0002, 301–796–4455. SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 51575 In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. JADELLE (levonorgestrel) implant, 75 mg, is the subject of NDA 20–544, held by Population Council, and initially approved on November 1, 1996. JADELLE (levonorgestrel) implants, 75 mg, are indicated for the prevention of pregnancy and are a long-term (up to 5 years) reversible method of contraception. Population Council has never marketed JADELLE (levonorgestrel) implant, 75 mg. Therefore, as in previous instances (see e.g., 72 FR 9763, 61 FR 25497), the Agency has determined, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product is equivalent to withdrawing the drug from sale. Arnall Golden Gregory, LLP submitted a citizen petition dated July SUPPLEMENTARY INFORMATION: E:\FR\FM\29AUN1.SGM 29AUN1 51576 Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 17, 2013 (Docket No. FDA–2013–P– 0886), under 21 CFR 10.30, requesting that the Agency determine whether JADELLE (levonorgestrel) implant, 75 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that JADELLE (levonorgestrel) implant, 75 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that JADELLE (levonorgestrel) implant, 75 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of JADELLE (levonorgestrel) implant, 75 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list JADELLE (levonorgestrel) implant, 75 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to JADELLE (levonorgestrel) implant, 75 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: August 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–20634 Filed 8–28–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES wreier-aviles on DSK5TPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2014–S–0009] Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Mar<15>2010 15:25 Aug 28, 2014 Jkt 232001 The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Electronic Submission of Lot Distribution Reports’’ dated August 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs). FDA recently published in the Federal Register a final rule requiring that, among other things, lot distribution reports be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help licensed manufacturers of products distributed under approved BLAs (henceforth referred to as applicants) comply with the final rule. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 28, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002 or Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–7800 or CDER at 301–796–3400. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911 or Jared Lantzy, Center for Drug Evaluation and Research (CDER), SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1116, Silver Spring, MD 20993–0002, email: esub@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Electronic Submission of Lot Distribution Reports’’ dated August 2014. The draft guidance provides information and recommendations pertaining to the electronic submission of lot distribution reports. The draft guidance provides information on how to electronically submit lot distribution reports for biological products under approved BLAs for which CBER or CDER has regulatory responsibility. When finalized, this guidance will not apply to any other biological product. FDA recently published in the Federal Register of June 10, 2014 (79 FR 33072), a final rule requiring electronic submission of certain postmarketing submissions. Among other things, under this rule applicants are required to submit biological lot distribution reports to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help applicants subject to lot distribution reporting comply with the final rule. Along with other information, the draft guidance provides updated information about the following: (1) Structured Product Labeling standard and vocabulary for electronic submission of lot distribution reporting; (2) additional resources such as implementation guide, validation procedures; and links with further information; and (3) procedures for requesting temporary waivers from the electronic submission requirement. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 600.81 and E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51575-51576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0886]


Determination That JADELLE (Levonorgestrel) Implant, 75 
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) has determined 
that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination will allow FDA to approve abbreviated new drug 
applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness 
(Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    JADELLE (levonorgestrel) implant, 75 mg, is the subject of NDA 20-
544, held by Population Council, and initially approved on November 1, 
1996. JADELLE (levonorgestrel) implants, 75 mg, are indicated for the 
prevention of pregnancy and are a long-term (up to 5 years) reversible 
method of contraception.
    Population Council has never marketed JADELLE (levonorgestrel) 
implant, 75 mg. Therefore, as in previous instances (see e.g., 72 FR 
9763, 61 FR 25497), the Agency has determined, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    Arnall Golden Gregory, LLP submitted a citizen petition dated July

[[Page 51576]]

17, 2013 (Docket No. FDA-2013-P-0886), under 21 CFR 10.30, requesting 
that the Agency determine whether JADELLE (levonorgestrel) implant, 75 
mg, was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that JADELLE (levonorgestrel) implant, 75 mg, was 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that JADELLE 
(levonorgestrel) implant, 75 mg, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of JADELLE (levonorgestrel) implant, 75 mg, 
from sale. We have also independently evaluated relevant literature and 
data for possible postmarketing adverse events. We have reviewed the 
available evidence and determined that this drug product was not 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list JADELLE 
(levonorgestrel) implant, 75 mg, in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. ANDAs that refer to JADELLE (levonorgestrel) implant, 75 
mg, may be approved by the Agency as long as they meet all other legal 
and regulatory requirements for the approval of ANDAs. If FDA 
determines that labeling for this drug product should be revised to 
meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20634 Filed 8-28-14; 8:45 am]
BILLING CODE 4164-01-P