Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 36312-36313 [2016-13181]

Download as PDF 36312 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices known, distribution, disposition, or expiration of the tissue, whichever is the latest. Section 1270.35(a) through (d) requires specific records to be maintained to document the following: (1) The results and interpretation of all required infectious disease tests; (2) information on the identity and relevant medical records of the donor; (3) the receipt and/or distribution of human tissue, and (4) the destruction or other disposition of human tissue. Respondents to this collection of information are manufacturers of human tissue intended for transplantation. Based on information from the Center for Biologics Evaluation and Research’s (CBER’s) database system, FDA estimates that there are approximately 383 tissue establishments of which 262 are conventional tissue banks and 121 are eye tissue banks. Based on information provided by industry, there are an estimated total of 2,141,960 conventional tissue products and 130,987 eye tissue products distributed per year with an average of 25 percent of the tissue discarded due to unsuitability for transplant. In addition, there are an estimated 29,799 deceased donors of conventional tissue and 70,027 deceased donors of eye tissue each year. Accredited members of the American Association of Tissue Banks (AATB) and Eye Bank Association of America (EBAA) adhere to standards of those organizations that are comparable to the recordkeeping requirements in part 1270. Based on information provided by CBER’s database system, 90 percent of the conventional tissue banks are members of AATB (262 × 90% = 236), and 95 percent of eye tissue banks are members of EBAA (121 × 95% = 115). Therefore, recordkeeping by these 351 establishments (236 + 115 = 351) is excluded from the burden estimates as usual and customary business activities (5 CFR 1320.3(b)(2)). The recordkeeping burden, thus, is estimated for the remaining 32 establishments, which is 8.36 percent of all establishments (383 ¥ 351 = 32, or 32/383 = 8.36%). FDA assumes that all current tissue establishments have developed written procedures in compliance with part 1270. Therefore, their information collection burden is for the general review and update of written procedures estimated to take an annual average of 24 hours, and for the recording and justifying of any deviations from the written procedures under § 1270.31(a) and (b), estimated to take an annual average of 1 hour. The information collection burden for maintaining records concurrently with the performance of each significant screening and testing step and for retaining records for 10 years under § 1270.33(a), (f), and (h) include documenting the results and interpretation of all required infectious disease tests and results and the identity and relevant medical records of the donor required under § 1270.35(a) and (b). Therefore, the burden under these provisions is calculated together in table 1 of this document. The recordkeeping estimates for the number of total annual records and hours per record are based on information provided by industry and FDA experience. FDA estimates the burden of this information collection as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers 21 CFR Section Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 1270.31(a), (b), (c), and (d) 2 ............................................... 1270.31(a) and 1270.31(b) 3 ................................................ 1270.33(a), (f), and (h), and 1270.35(a) and (b) ................. 1270.35(c) ............................................................................ 1270.35(d) ............................................................................ 32 32 32 32 32 1 2 6,198.84 11,876.12 1,454.50 32 64 198,363 380,036 47,504 24 1 1.0 1.0 1.0 768 64 198,363 380,036 47,504 Total .............................................................................. ........................ ........................ ........................ ........................ 626,735 1 There are no capital costs or operating and maintenance costs associated with this collection of information. and update of standard operating procedures (SOPs). 3 Documentation of deviations from SOPs. 2 Review Dated: May 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13224 Filed 6–3–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration sradovich on DSK3TPTVN1PROD with NOTICES [Docket No. FDA–2016–N–1284] Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 16:36 Jun 03, 2016 Jkt 238001 The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. SUMMARY: FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 approved 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\06JNN1.SGM 06JNN1 36313 Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices 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 generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is 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). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person Application No. Drug name Active ingredient(s) NDA 008303 .......... APRESOLINE ...... Hydralazine Hydrochloride; NDA 017853 .......... PROVENTIL ......... Albuterol Sulfate .................. NDA 019439 .......... K-Dur .................... Potassium Chloride ............. ANDA 060572 ....... MYCOLOG–II ....... ANDA 084343 ....... KENALOG ............ Nystatin; Triamcinolone Acetonide. Triamcinolone Acetonide ..... FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: May 31, 2016. Leslie Kux, Associate Commissioner for Policy. sradovich on DSK3TPTVN1PROD with NOTICES [FR Doc. 2016–13181 Filed 6–3–16; 8:45 am] BILLING CODE 4164–01–P Strength(s) Dosage form/route 20 milligrams (mg)/milliliter 10 mg; 25 mg; 50 mg; 100 mg. Equivalent to (EQ) 2 mg base; EQ 4 mg base. 10 milliequivalents (meq); 20 meq. 100,000 units/gram; 0.1% ... 0.025%; 0.1% ...................... Novartis Pharmaceuticals Corp. Tablet; Oral .......................... Schering-Plough Corp. Extended-Release Tablet; Oral. Ointment; Topical ................ Merck Sharp & Dohme, Corp. Delcor Asset Corp. Lotion; Topical ..................... Delcor Asset Corp. Food and Drug Administration [Docket No. FDA–2016–D–0643] Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ‘‘Labeling for Biosimilar Products; Draft Guidance for Industry; Availability’’ that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the VerDate Sep<11>2014 16:36 Jun 03, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Applicant Injectable; Injection Tablet; Oral. DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the following table are no longer being marketed. instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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.’’ E:\FR\FM\06JNN1.SGM 06JNN1

Agencies

[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36312-36313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13181]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1284]


Determination That APRESOLINE (Hydralazine Hydrochloride) 
Injectable and Other Drug Products Were 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 the drug products listed in this document were 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 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to the products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
Stacy.Kane@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 approved 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.

[[Page 36313]]

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 generally known as the 
``Orange Book.'' Under FDA regulations, a drug is 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).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the following 
table are no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                                   Active                         Dosage form/
   Application No.           Drug name         ingredient(s)     Strength(s)         route          Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008303...........  APRESOLINE...........  Hydralazine      20 milligrams    Injectable;      Novartis
                                               Hydrochloride;.  (mg)/            Injection        Pharmaceutical
                                                                milliliter 10    Tablet; Oral.    s Corp.
                                                                mg; 25 mg; 50
                                                                mg; 100 mg.
NDA 017853...........  PROVENTIL............  Albuterol        Equivalent to    Tablet; Oral...  Schering-Plough
                                               Sulfate.         (EQ) 2 mg                         Corp.
                                                                base; EQ 4 mg
                                                                base.
NDA 019439...........  K-Dur................  Potassium        10               Extended-        Merck Sharp &
                                               Chloride.        milliequivalen   Release          Dohme, Corp.
                                                                ts (meq); 20     Tablet; Oral.
                                                                meq.
ANDA 060572..........  MYCOLOG-II...........  Nystatin;        100,000 units/   Ointment;        Delcor Asset
                                               Triamcinolone    gram; 0.1%.      Topical.         Corp.
                                               Acetonide.
ANDA 084343..........  KENALOG..............  Triamcinolone    0.025%; 0.1%...  Lotion; Topical  Delcor Asset
                                               Acetonide.                                         Corp.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the Agency will continue to list the drug products listed 
in this document in the ``Discontinued Drug Product List'' section of 
the Orange Book. The ``Discontinued Drug Product List'' identifies, 
among other items, drug products that have been discontinued from 
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this 
document are unaffected by the discontinued marketing of the products 
subject to those NDAs and ANDAs. Additional ANDAs that refer to these 
products may also be approved by the Agency if they comply with 
relevant legal and regulatory requirements. If FDA determines that 
labeling for these drug products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13181 Filed 6-3-16; 8:45 am]
 BILLING CODE 4164-01-P
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