Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry; Availability, 81779-81780 [2016-27768]

Download as PDF Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, 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 that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: V. Ellen Maher, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993–0002, 301–796–5017; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.’’ This draft guidance is intended to provide a framework for industry to facilitate the development of drugs and biologics to treat patients with nonmuscle invasive bladder cancer (NMIBC). The focus is on the subset of patients with BCG-unresponsive disease. In addition, the pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints, are discussed. The preferred trial design for demonstrating efficacy of drugs developed to treat NMIBC is a randomized, controlled trial with a time-to-event endpoint of recurrencefree survival. Single-arm trials are appropriate in clinical settings for which a randomized, controlled trial is either unethical or not feasible. Therefore, single-arm trials of patients with BCG-unresponsive carcinoma in situ with or without papillary disease using an endpoint of complete response rate (and duration) may be appropriate. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drugs and biologics for VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 the treatment of BCG-unresponsive NMIBC. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This draft 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 parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. 81779 make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissuebased products (HCT/Ps) with information on infectious-disease risks related to receipt of FDA licensed human-derived clotting factor concentrates (HDCFCs). The guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. The guidance supplements the recommendations regarding HDCFCs that are contained in the guidance entitled ‘‘Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry’’ dated August 2007. The Agency is soliciting public comment, but is implementing this guidance immediately because the Agency has determined that prior public participation is not appropriate. Submit either electronic or written comments on Agency guidances at any time. DATES: Dated: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. ADDRESSES: [FR Doc. 2016–27762 Filed 11–17–16; 8:45 am] Electronic Submissions BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–3750] Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ‘‘Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received HumanDerived Clotting Factor Concentrates; Guidance for Industry.’’ The guidance document provides establishments that SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 You may submit comments as follows: Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the 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’’). E:\FR\FM\18NON1.SGM 18NON1 81780 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES 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.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–D–3750 for ‘‘Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received HumanDerived Clotting Factor Concentrates; Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to 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 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received HumanDerived Clotting Factor Concentrates; Guidance for Industry.’’ The guidance document provides establishments that make DE determinations for donors of HCT/Ps with information on infectious disease risks related to receipt of HDCFCs. The guidance explains that FDA no longer considers FDA licensed HDCFCs as a risk factor for HIV, HBV, or HCV. As such, receipt of FDA licensed HDCFCs, or sex with a person who has received FDA licensed HDCFCs, should not be considered a risk factor when determining eligibility of a donor of HCT/Ps. The recommendations in the guidance supersede the recommendations contained in section IV.E.3. of the guidance entitled ‘‘Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps); Guidance for Industry’’ dated August 2007. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without initially seeking prior comment because the Agency has determined that prior public participation is not appropriate. This guidance recommends a less burdensome policy that is consistent with the public health. The guidance represents the current thinking of FDA on ‘‘Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it 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 1271.47 have been approved under OMB control number 0910–0543. III. 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: November 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–27768 Filed 11–17–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–3680] Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were 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 SUMMARY: E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81779-81780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27768]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3750]


Revised Recommendations for Determining Eligibility of Donors of 
Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have 
Received Human-Derived Clotting Factor Concentrates; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``Revised Recommendations for 
Determining Eligibility of Donors of Human Cells, Tissues, and Cellular 
and Tissue-Based Products Who Have Received Human-Derived Clotting 
Factor Concentrates; Guidance for Industry.'' The guidance document 
provides establishments that make donor eligibility (DE) determinations 
for donors of human cells, tissues, and cellular and tissue-based 
products (HCT/Ps) with information on infectious-disease risks related 
to receipt of FDA licensed human-derived clotting factor concentrates 
(HDCFCs). The guidance explains that FDA no longer considers FDA 
licensed HDCFCs as a risk factor for human immunodeficiency virus 
(HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, 
receipt of FDA licensed HDCFCs, or sex with a person who has received 
FDA licensed HDCFCs, should not be considered a risk factor when 
determining eligibility of a donor of HCT/Ps. The guidance supplements 
the recommendations regarding HDCFCs that are contained in the guidance 
entitled ``Eligibility Determination for Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for 
Industry'' dated August 2007.

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately because the Agency has determined that prior 
public participation is not appropriate. Submit either electronic or 
written comments on Agency guidances at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the 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'').

[[Page 81780]]

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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-3750 for ``Revised Recommendations for Determining 
Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products Who Have Received Human-Derived Clotting Factor 
Concentrates; Guidance for Industry.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to 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 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Revised 
Recommendations for Determining Eligibility of Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products Who Have Received 
Human-Derived Clotting Factor Concentrates; Guidance for Industry.'' 
The guidance document provides establishments that make DE 
determinations for donors of HCT/Ps with information on infectious 
disease risks related to receipt of HDCFCs. The guidance explains that 
FDA no longer considers FDA licensed HDCFCs as a risk factor for HIV, 
HBV, or HCV. As such, receipt of FDA licensed HDCFCs, or sex with a 
person who has received FDA licensed HDCFCs, should not be considered a 
risk factor when determining eligibility of a donor of HCT/Ps. The 
recommendations in the guidance supersede the recommendations contained 
in section IV.E.3. of the guidance entitled ``Eligibility Determination 
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps); Guidance for Industry'' dated August 2007.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). FDA is issuing this guidance for 
immediate implementation in accordance with 21 CFR 10.115(g)(2) without 
initially seeking prior comment because the Agency has determined that 
prior public participation is not appropriate. This guidance recommends 
a less burdensome policy that is consistent with the public health. The 
guidance represents the current thinking of FDA on ``Revised 
Recommendations for Determining Eligibility of Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products Who Have Received 
Human-Derived Clotting Factor Concentrates.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it 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 1271.47 have been approved under 
OMB control number 0910-0543.

III. 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: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27768 Filed 11-17-16; 8:45 am]
 BILLING CODE 4164-01-P
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