Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction, 25060 [2019-11313]

Download as PDF 25060 Federal Register / Vol. 84, No. 104 / Thursday, May 30, 2019 / Notices described in individual information collection requests. These data will be compared to benchmarks from the relevant CAHPS source surveys when available. Collection of these data from people who have been identified through CMS administrative data and administrative flags as part of specific minority populations will also serve as a critical validation step of this method for identifying difficult-to-study populations, thus making it easier to study beneficiaries in these groups in the future. Form Number: CMS–10701 (OMB control number: 0938–NEW); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 10,000; Total Annual Responses: 10,000; Total Annual Hours: 3,333. (For policy questions regarding this collection contact Luis Perez at 410–786–8557.) Dated: May 23, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993–0002, 240– 402–4246. SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, May 10, 2019 (84 FR 20633), in FR Doc. 2019– 09692, the following correction is made: On page 20633, in the first column, in the headings of the document, ‘‘[Docket No. FDA–2019–D–1798]’’ is corrected to read ‘‘[Docket No. FDA–2018–D–1456].’’ Dated: May 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–11313 Filed 5–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–P–4851] Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness [FR Doc. 2019–11227 Filed 5–29–19; 8:45 am] BILLING CODE 4120–01–P AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA–2018–D–1456] Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Overthe-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability’’ that appeared in the Federal Register of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:08 May 29, 2019 Jkt 247001 The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Meadow Platt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993–0002, 301– 796–1830, Meadow.Platt@fda.hhs.gov. 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 SUMMARY: Food and Drug Administration AGENCY: Notice. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 (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. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is the subject of NDA 019010, held by Abbvie Endocrine, Inc., and initially approved on April 9, 1985. LUPRON is indicated for palliative treatment of advanced prostatic cancer. LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Hetero Labs Limited submitted a citizen petition dated December 20, 2018 (Docket No. FDA–2018–P–4851), under 21 CFR 10.30, requesting that the Agency determine whether LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, 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 LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Page 25060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1456]


Maximal Usage Trials for Topically Applied Active Ingredients 
Being Considered for Inclusion in an Over-the-Counter Monograph: Study 
Elements and Considerations; Guidance for Industry; Availability; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Maximal Usage Trials for Topically Applied Active 
Ingredients Being Considered for Inclusion in an Over-the-Counter 
Monograph: Study Elements and Considerations; Guidance for Industry; 
Availability'' that appeared in the Federal Register of May 10, 2019. 
The document announced the availability of a guidance for industry. The 
document was published with the incorrect docket number. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, May 10, 
2019 (84 FR 20633), in FR Doc. 2019-09692, the following correction is 
made:
    On page 20633, in the first column, in the headings of the 
document, ``[Docket No. FDA-2019-D-1798]'' is corrected to read 
``[Docket No. FDA-2018-D-1456].''

    Dated: May 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11313 Filed 5-29-19; 8:45 am]
 BILLING CODE 4164-01-P
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