Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria; Availability, 50421-50422 [2013-19962]

Download as PDF Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices 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of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved; (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved; and (3) when a person 50421 petitions for such a determination under 21 CFR 10.25(a) and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 Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to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 table in this document are no longer being marketed. Application No. Drug Applicant NDA 016908 ............. LIDEX (fluocinonide) Cream; Topical, 0.05%, ...................... Do. ............................ NDA 018181 ............. NDA 018713 ............. NDA 019510 ............. LIDEX–E (fluocinonide) Cream; Topical, 0.05% ................... MYCELEX (clotrimazole) Solution; Topical, 1% ................... MYCELEX (clotrimazole) Lozenge; Oral, 10 milligrans (mg) PEPCID (famotidine) Injection, 10 mg/milliliter (mL) ............ Do. ............................ PEPCID PRESERVATIVE FREE (famotidine) Injection, 10 mg/mL. PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (famotidine) Injection, 0.4 mg/mL. FEMHRT (ethinyl estradiol; norethindrone acetate) Tablet; Oral, 0.005 mg/1 mg. MITOZYTREX (mitomycin) Injection, 5 mg/vial .................... Medicis Pharmaceutical Corp., 7720 North Dobson Rd., Scottsdale, AZ 85256. Do. Bayer Health Care, 100 Bayer Rd., Pittsburgh, PA 15205. Do. Merck Research Laboratories, Inc., 770 Sumneytown Pike, West Point, PA 19486. Do. NDA 020249 ............. NDA 021065 ............. NDA 050763 ............. ANDA 086031 .......... TKELLEY on DSK3SPTVN1PROD with NOTICES ANDA 086033 .......... Warner Chilcott LLC, 1 Grand Canal Sq., Docklands, Dublin 2, Ireland. SuperGen, Inc., 4140 Dublin Blvd., Suite 200, Dublin, CA 94568. Watson Laboratories, 577 Chipeta Way, Salt Lake City, UT 84108. Do. ISOSORBIDE DINITRATE (isosorbide dinitrate) Tablet; Sublingual, 5 mg. ISOSORBIDE DINITRATE (isosorbide dinitrate) Tablet; Sublingual, 2.5 mg. 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. VerDate Mar<15>2010 Do. 17:51 Aug 16, 2013 Jkt 229001 Dated: August 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20086 Filed 8–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2000–D–0187 (formerly Docket No. 2000D–1267)] Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria’’ dated August 2013. The guidance document provides blood SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes the FDA memorandum to all registered blood establishments entitled ‘‘Recommendations for Deferral of Donors for Malaria Risk’’ dated July 26, 1994. The recommendations contained in the guidance are not applicable to donors of Source Plasma. Submit either electronic or written comments on Agency guidances at any time. DATES: Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. 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 ADDRESSES: E:\FR\FM\19AUN1.SGM 19AUN1 50422 Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Notices 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: Melissa Reisman, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: TKELLEY on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria’’ dated August 2013. The guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, and allowing their reentry, to reduce the risk of transfusiontransmitted malaria. This guidance document also provides recommendations for product management, including recommendations regarding product retrieval and quarantine, and notification of consignees of blood and blood components in the event that a blood establishment determines that blood or blood components have been collected from a donor who should have been deferred due to possible malaria risk. Finally, the guidance contains recommendations on the implementation of FDA’s recommendations, including how licensed blood establishments must report to FDA the changes made to their donor history questionnaires to reflect the new donor deferral recommendations. In the Federal Register of July 6, 2012 (77 FR 40068), FDA announced the availability of the draft guidance of the same title dated June 2012. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. Significant changes to the guidance include: revisions to the definition of malaria-endemic area, malaria-endemic country and other terms used to assess a donor’s risk of malaria based on history of travel or residence; and revisions to the VerDate Mar<15>2010 17:51 Aug 16, 2013 Jkt 229001 recommendations regarding consignee notification and reporting of biological product deviations for acellular blood components collected from a donor at risk for malaria. Based on the revised definition of malaria-endemic area and current epidemiological data, donors who travel to the Mexican States of Quintana Roo or Jalisco would be eligible for donation without any deferral, provided the donors meet all other eligibility criteria. However, if malaria transmission in these States changes over time, the donor deferral recommendations would encompass donors who travel to these areas. The guidance announced in this notice finalizes the draft guidance dated June 2012, and supersedes the FDA memorandum to all registered blood establishments entitled ‘‘Recommendations for Deferral of Donors for Malaria Risk,’’ dated July 26, 1994. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents 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 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 part 640 and 21 CFR 630.6 have been approved under OMB control number 0910–0116. The collections of information in 21 CFR 606.171 have been approved under OMB control number 0910–0458. III. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or https://www.regulations.gov. Dated: August 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19962 Filed 8–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–M–0462, FDA– 2013–M–0463, FDA–2013–M–0464, FDA– 2013–M–0549, FDA–2013–M–0592, FDA– 2013–M–0594, FDA–2013–M–0595, FDA– 2013–M–0709, FDA–2013–M–0724, FDA– 2013–M–0738, and FDA–2013–M–0758] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–6570. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50421-50422]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0187 (formerly Docket No. 2000D-1267)]


Guidance for Industry: Recommendations for Donor Questioning, 
Deferral, Reentry, and Product Management To Reduce the Risk of 
Transfusion-Transmitted Malaria; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: 
Recommendations for Donor Questioning, Deferral, Reentry and Product 
Management to Reduce the Risk of Transfusion-Transmitted Malaria'' 
dated August 2013. The guidance document provides blood establishments 
that collect blood and blood components with recommendations for 
questioning and deferring donors of blood and blood components, 
allowing their reentry, and product management to reduce the risk of 
transfusion-transmitted malaria. This guidance finalizes the draft 
guidance of the same title dated June 2012, and supersedes the FDA 
memorandum to all registered blood establishments entitled 
``Recommendations for Deferral of Donors for Malaria Risk'' dated July 
26, 1994. The recommendations contained in the guidance are not 
applicable to donors of Source Plasma.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Office of Communication, Outreach and Development (HFM-40), 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. 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

[[Page 50422]]

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: Melissa Reisman, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Guidance for Industry: Recommendations for Donor Questioning, 
Deferral, Reentry and Product Management to Reduce the Risk of 
Transfusion-Transmitted Malaria'' dated August 2013. The guidance 
document provides blood establishments that collect blood and blood 
components with recommendations for questioning and deferring donors of 
blood and blood components, and allowing their reentry, to reduce the 
risk of transfusion-transmitted malaria. This guidance document also 
provides recommendations for product management, including 
recommendations regarding product retrieval and quarantine, and 
notification of consignees of blood and blood components in the event 
that a blood establishment determines that blood or blood components 
have been collected from a donor who should have been deferred due to 
possible malaria risk. Finally, the guidance contains recommendations 
on the implementation of FDA's recommendations, including how licensed 
blood establishments must report to FDA the changes made to their donor 
history questionnaires to reflect the new donor deferral 
recommendations.
    In the Federal Register of July 6, 2012 (77 FR 40068), FDA 
announced the availability of the draft guidance of the same title 
dated June 2012. FDA received several comments on the draft guidance 
and those comments were considered as the guidance was finalized. 
Significant changes to the guidance include: revisions to the 
definition of malaria-endemic area, malaria-endemic country and other 
terms used to assess a donor's risk of malaria based on history of 
travel or residence; and revisions to the recommendations regarding 
consignee notification and reporting of biological product deviations 
for acellular blood components collected from a donor at risk for 
malaria. Based on the revised definition of malaria-endemic area and 
current epidemiological data, donors who travel to the Mexican States 
of Quintana Roo or Jalisco would be eligible for donation without any 
deferral, provided the donors meet all other eligibility criteria. 
However, if malaria transmission in these States changes over time, the 
donor deferral recommendations would encompass donors who travel to 
these areas. The guidance announced in this notice finalizes the draft 
guidance dated June 2012, and supersedes the FDA memorandum to all 
registered blood establishments entitled ``Recommendations for Deferral 
of Donors for Malaria Risk,'' dated July 26, 1994.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 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 part 640 and 21 CFR 630.6 have 
been approved under OMB control number 0910-0116. The collections of 
information in 21 CFR 606.171 have been approved under OMB control 
number 0910-0458.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19962 Filed 8-16-13; 8:45 am]
BILLING CODE 4160-01-P
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