Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 34313-34314 [2014-13906]

Download as PDF Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 / Notices strategies, messages, labels, and labeling. These communications will aim to improve public understanding of the risks and benefits of using regulated animal drugs, feed, food additives, and devices by providing users with a better context in which to place risk information more completely. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the developmental stage. Respondents will be asked to give their reaction to the messages in either individual or group settings. Third, as evaluative research, it will allow FDA to ascertain the effectiveness 34313 of the messages and the distribution method of these messages in achieving the objectives of the message campaign. Evaluation of campaigns is a vital link in continuous improvement of communications at FDA. FDA estimates the burden of this collection of information based on recent prior experience with the various types of data collection methods described in this document: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 U.S.C. 393(d)(2)(D) Number of responses per respondent Average burden per response Total annual responses Total hours Individual Indepth Interviews ....................................... General Public Focus Group Interviews ..................... Intercept Interviews: Central Location ......................... Intercept Interviews: Telephone .................................. Self-Administered Surveys .......................................... Gatekeeper Reviews ................................................... Omnibus Surveys ........................................................ Total (General Public) ................................................. Veterinarian/Scientific Expert Focus Group Interviews Total (Veterinarians/Scientific Experts) ....................... 360 288 600 2 10,000 2,400 400 2,400 16,448 288 288 1 1 1 1 1 1 1 ........................ 1 1 360 288 600 10,000 2,400 400 2,400 16,448 288 288 0.75 (45 minutes) .. 1.5 .......................... 0.25 (15 minutes) .. 0.08 (5 minutes) ..... 0.25 (15 minutes) ... 0.50 (30 minutes) ... 0.17 (10 minutes) ... ................................ 0.75 ........................ ................................ 270 432 150 800 600 200 408 2,860 216 216 Total (Overall) ....................................................... 16,736 1 16,736 ................................ 3,076 1 There 2 These are no capital costs or operating and maintenance costs associated with this collection of information. are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 number. Annually, FDA projects about 30 studies with 16,736 respondents, using a variety of research methods and lasting an average of 0.17 hours each (varying from 0.08–1.5 hours). Dated: June 9, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13929 Filed 6–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–P–1654] Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness emcdonald on DSK67QTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 milligrams (mg)/1 milliliter (mL), 10 mL total fill volume, was not withdrawn SUMMARY: VerDate Mar<15>2010 16:36 Jun 13, 2014 Jkt 232001 from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993–0002, 240– 402–0978. 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). PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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. LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, is the subject of ANDA 40147, held by Hospira, Inc. (Hospira), and was initially approved on June 25, 1997. LEUCOVORIN CALCIUM- E:\FR\FM\16JNN1.SGM 16JNN1 emcdonald on DSK67QTVN1PROD with NOTICES 34314 Federal Register / Vol. 79, No. 115 / Monday, June 16, 2014 / Notices PRESERVATIVE FREE is indicated for treatment of megaloblastic anemia and to counteract the therapeutic and toxic effects of folic acid antagonists. In a letter dated January 14, 2005, Hospira notified FDA that LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Gordon Johnston, on behalf of Gordon Johnston Regulatory Consultants, LLC, submitted a citizen petition dated December 13, 2013 (Docket No. FDA– 2013–P–1654), under 21 CFR 10.30, requesting that the Agency determine whether LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of LEUCOVORIN CALCIUMPRESERVATIVE FREE Injection, 10 mg/ 1 mL, 10 mL total fill volume, 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 product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, may be approved by the Agency as long as they meet all other legal and regulatory requirements for VerDate Mar<15>2010 16:36 Jun 13, 2014 Jkt 232001 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: June 10, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–13906 Filed 6–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0011] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6 on Uniformity of Dosage Units General Chapter; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ‘‘Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions’’ (core ICH Q4B guidance). SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or 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. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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: Regarding the guidance: Robert H. King, CDER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4166, Silver Spring, MD 20993–0002, 301–796–1242; or Stephen Ripley, CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. Regarding the ICH: Michelle Limoli, CDER, International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3342, Silver Spring, MD 20993–0002, 301– 796–8377. SUPPLEMENTARY INFORMATION: DATES: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input E:\FR\FM\16JNN1.SGM 16JNN1

Agencies

[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Notices]
[Pages 34313-34314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13906]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1654]


Determination That LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 Milligrams/1 Milliliter, 10 Milliliter Total Fill Volume, 
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) has determined that 
LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 milligrams (mg)/1 
milliliter (mL), 10 mL total fill volume, was not withdrawn from sale 
for reasons of safety or effectiveness. This determination will allow 
FDA to approve abbreviated new drug applications (ANDAs) for LEUCOVORIN 
CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill 
volume, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240-
402-0978.

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.
    LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL 
total fill volume, is the subject of ANDA 40147, held by Hospira, Inc. 
(Hospira), and was initially approved on June 25, 1997. LEUCOVORIN 
CALCIUM-

[[Page 34314]]

PRESERVATIVE FREE is indicated for treatment of megaloblastic anemia 
and to counteract the therapeutic and toxic effects of folic acid 
antagonists.
    In a letter dated January 14, 2005, Hospira notified FDA that 
LEUCOVORIN CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total 
fill volume, was being discontinued, and FDA moved the drug product to 
the ``Discontinued Drug Product List'' section of the Orange Book.
    Gordon Johnston, on behalf of Gordon Johnston Regulatory 
Consultants, LLC, submitted a citizen petition dated December 13, 2013 
(Docket No. FDA-2013-P-1654), under 21 CFR 10.30, requesting that the 
Agency determine whether LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 mg/1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-PRESERVATIVE FREE 
Injection, 10 mg/1 mL, 10 mL total fill volume, was not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of LEUCOVORIN 
CALCIUM-PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill 
volume, 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 product was 
not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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 LEUCOVORIN CALCIUM-
PRESERVATIVE FREE Injection, 10 mg/1 mL, 10 mL total fill volume, 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: June 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13906 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P

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