Determination That DOBUTREX (Dobutamine Hydrochloride), Equivalent 12.5 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 83095-83096 [2020-28080]

Download as PDF 83095 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 21 CFR section/activity 511.1(b)(7); maintain records of the investigation, including records of the receipt and disposition of each shipment or delivery of the investigational new animal drug ..................... 511.1(b)(8)(i); maintain records of all reports received by a sponsor from investigators ..................................................... Total ........................................................................................... 1 There No. of recordkeepers No. of records per recordkeeper 279 5.94 279 ........................ 5.94 ........................ Average burden per recordkeeping Total hours 1,657 3.5 5,800 1,657 5,247 3.5 ........................ 5,800 13,533 Total annual records are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the time required for reporting requirements, record preparation, and maintenance for this collection of information is based on our informal communication with industry. Based on the number of sponsors subject to animal drug user fees, we estimate that there are 279 respondents. We use this estimate consistently throughout the table and calculate the ‘‘number of responses per respondent’’ by dividing the total annual responses by number of respondents. We note an apparent difference in the estimated number of respondents from the previous renewal issued in 2018. There was an error in calculating the number of sponsors subject to animal drug user fees in the 2018 renewal. When calculating the number of recordkeepers, we inadvertently used the number of sponsors that paid user fees (i.e., those that did not qualify for user fee waivers) as opposed to the total number of sponsors subject to animal drug user fees. Both fee-paying and nonfee-paying sponsors are respondents with respect to this information collection. Additional information needed to make a final calculation of the total burden hours (i.e., the number of respondents, the number of recordkeepers, the number of NCIEs received, etc.) is derived from our records. There is a small increase in the total burden hours which we attribute to an increase in the number of annual responses and records. Dated: December 14, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–28068 Filed 12–18–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 22:33 Dec 18, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–P–1650] Determination That DOBUTREX (Dobutamine Hydrochloride), Equivalent 12.5 Milligram Base/ Milliliter, 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 Agency) has determined that DOBUTREX (dobutamine hydrochloride), equivalent (eq) 12.5 milligram (mg) base/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: Jessica Tierney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301– 796–9120, Jessica.Tierney@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 dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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. DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, is the subject of NDA 017820, held by Eli Lilly and Co., and initially approved on July 18, 1978. DOBUTREX is indicated for when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Cardinal Health submitted a citizen petition dated July 9, 2020 (Docket No. FDA–2020–P–1650), under 21 CFR 10.30, requesting that the Agency determine whether DOBUTREX E:\FR\FM\21DEN1.SGM 21DEN1 83096 Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices (dobutamine hydrochloride), eq 12.5 mg base/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 DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, 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 DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, 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. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also 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: December 16, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–28080 Filed 12–18–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 22:33 Dec 18, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0417] Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective February 1, 2021, with this notice. 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. DATES: Nominations received on or before February 19, 2021, will be given first consideration for membership on the National Mammography Quality Assurance Advisory Committee. Nominations received after February 19, 2021, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal at 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 on 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: Regarding all nomination questions for membership: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993, 301–796– 0400, Aden.Asefa@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 members to fill upcoming vacancies on the National Mammography Quality Assurance Advisory Committee. I. General Description of the Committee Duties The National Mammography Quality Assurance Advisory Committee advises the Commissioner of Food and Drugs (the Commissioner) or designee 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 such 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. Criteria for Voting Members The committee consists of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete re´sume´ or curriculum vitae for each nominee, including current business address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83095-83096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28080]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-1650]


Determination That DOBUTREX (Dobutamine Hydrochloride), 
Equivalent 12.5 Milligram Base/Milliliter, 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 Agency) has 
determined that DOBUTREX (dobutamine hydrochloride), equivalent (eq) 
12.5 milligram (mg) base/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: Jessica Tierney, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120, [email protected].

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 (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.
    DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, is the 
subject of NDA 017820, held by Eli Lilly and Co., and initially 
approved on July 18, 1978. DOBUTREX is indicated for when parenteral 
therapy is necessary for inotropic support in the short-term treatment 
of adults with cardiac decompensation due to depressed contractility 
resulting either from organic heart disease or from cardiac surgical 
procedures. DOBUTREX (dobutamine hydrochloride), eq 12.5 mg base/mL, is 
currently listed in the ``Discontinued Drug Product List'' section of 
the Orange Book.
    Cardinal Health submitted a citizen petition dated July 9, 2020 
(Docket No. FDA-2020-P-1650), under 21 CFR 10.30, requesting that the 
Agency determine whether DOBUTREX

[[Page 83096]]

(dobutamine hydrochloride), eq 12.5 mg base/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 Sec.  314.161 that DOBUTREX (dobutamine hydrochloride), eq 12.5 
mg base/mL, was not withdrawn for reasons of safety or effectiveness. 
The petitioner has identified no data or other information suggesting 
that this drug product was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of DOBUTREX (dobutamine hydrochloride), eq 
12.5 mg base/mL, 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 DOBUTREX (dobutamine 
hydrochloride), eq 12.5 mg base/mL, 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also 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: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28080 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P

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