81 FR 81779 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81779-81780 | |
| FR Document | 2016-27768 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81779-81780] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81779
Division of Drug Information, Center for the treatment of BCG-unresponsive make donor eligibility (DE)
Drug Evaluation and Research, Food NMIBC. It does not establish any rights determinations for donors of human
and Drug Administration, 10001 New for any person and is not binding on cells, tissues, and cellular and tissue-
Hampshire Ave., Hillandale Building, FDA or the public. You can use an based products (HCT/Ps) with
4th Floor, Silver Spring, MD 20993– alternative approach if it satisfies the information on infectious-disease risks
0002, or the Office of Communication, requirements of the applicable statutes related to receipt of FDA licensed
Outreach, and Development, Center for and regulations. human-derived clotting factor
Biologics Evaluation and Research, II. The Paperwork Reduction Act of concentrates (HDCFCs). The guidance
Food and Drug Administration, 10903 1995 explains that FDA no longer considers
New Hampshire Ave., Bldg. 71, Rm. FDA licensed HDCFCs as a risk factor
3128, Silver Spring, MD 20993–0002. This draft guidance refers to for human immunodeficiency virus
Send one self-addressed adhesive label previously approved collections of (HIV), Hepatitis B virus (HBV), or
to assist that office in processing your information found in FDA regulations. Hepatitis C virus (HCV). As such,
requests. See the SUPPLEMENTARY These collections of information are receipt of FDA licensed HDCFCs, or sex
INFORMATION section for electronic subject to review by the Office of with a person who has received FDA
access to the draft guidance document. Management and Budget (OMB) under licensed HDCFCs, should not be
the Paperwork Reduction Act of 1995 considered a risk factor when
FOR FURTHER INFORMATION CONTACT: V.
(44 U.S.C. 3501–3520). The collections determining eligibility of a donor of
Ellen Maher, Center for Drug Evaluation
of information in 21 CFR parts 312 and HCT/Ps. The guidance supplements the
and Research, Food and Drug
314 have been approved under OMB recommendations regarding HDCFCs
Administration, 10903 New Hampshire
control numbers 0910–0014 and 0910– that are contained in the guidance
Ave., Bldg. 22, Rm. 2352, Silver Spring,
0001, respectively. entitled ‘‘Eligibility Determination for
MD 20993–0002, 301–796–5017; or
Stephen Ripley, Center for Biologics III. Electronic Access Donors of Human Cells, Tissues, and
Evaluation and Research, Food and Cellular and Tissue-Based Products
Persons with access to the Internet
Drug Administration, 10903 New (HCT/Ps); Guidance for Industry’’ dated
may obtain the draft guidance at http://
Hampshire Ave., Bldg. 71, Rm. 7301, August 2007.
www.fda.gov/Drugs/Guidance
Silver Spring, MD 20993–0002, 240– ComplianceRegulatoryInformation/ DATES: The Agency is soliciting public
402–7911. Guidances/default.htm, http:// comment, but is implementing this
SUPPLEMENTARY INFORMATION: www.fda.gov/BiologicsBloodVaccines/ guidance immediately because the
GuidanceComplianceRegulatory Agency has determined that prior public
I. Background
Information/default.htm, or http:// participation is not appropriate. Submit
FDA is announcing the availability of www.regulations.gov. either electronic or written comments
a draft guidance for industry entitled on Agency guidances at any time.
Dated: November 14, 2016.
‘‘BCG-Unresponsive Nonmuscle
Leslie Kux, ADDRESSES: You may submit comments
Invasive Bladder Cancer: Developing
Associate Commissioner for Policy. as follows:
Drugs and Biologics for Treatment.’’
This draft guidance is intended to [FR Doc. 2016–27762 Filed 11–17–16; 8:45 am] Electronic Submissions
provide a framework for industry to BILLING CODE 4164–01–P
facilitate the development of drugs and Submit electronic comments in the
biologics to treat patients with following way:
nonmuscle invasive bladder cancer DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: http://
(NMIBC). The focus is on the subset of HUMAN SERVICES www.regulations.gov. Follow the
patients with BCG-unresponsive instructions for submitting comments.
Food and Drug Administration Comments submitted electronically,
disease. In addition, the pathological
diagnosis and staging, risk stratification, [Docket No. FDA–2016–D–3750] including attachments, to http://
and trial design, including assessment www.regulations.gov will be posted to
of appropriate clinical endpoints, are Revised Recommendations for the docket unchanged. Because your
discussed. Determining Eligibility of Donors of comment will be made public, you are
The preferred trial design for Human Cells, Tissues, and Cellular and solely responsible for ensuring that your
demonstrating efficacy of drugs Tissue-Based Products Who Have comment does not include any
developed to treat NMIBC is a Received Human-Derived Clotting confidential information that you or a
randomized, controlled trial with a Factor Concentrates; Guidance for third party may not wish to be posted,
time-to-event endpoint of recurrence- Industry; Availability such as medical information, your or
free survival. Single-arm trials are AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
appropriate in clinical settings for HHS. confidential business information, such
which a randomized, controlled trial is as a manufacturing process. Please note
ACTION: Notice of availability. that if you include your name, contact
either unethical or not feasible.
Therefore, single-arm trials of patients SUMMARY: The Food and Drug information, or other information that
with BCG-unresponsive carcinoma in Administration (FDA or Agency) is identifies you in the body of your
situ with or without papillary disease announcing the availability of a comments, that information will be
using an endpoint of complete response document entitled ‘‘Revised posted on http://www.regulations.gov.
mstockstill on DSK3G9T082PROD with NOTICES
rate (and duration) may be appropriate. Recommendations for Determining • If you want to submit a comment
This draft guidance is being issued Eligibility of Donors of Human Cells, with confidential information that you
consistent with FDA’s good guidance Tissues, and Cellular and Tissue-Based do not wish to be made available to the
practices regulation (21 CFR 10.115). Products Who Have Received Human- public, submit the comment as a
The draft guidance, when finalized, will Derived Clotting Factor Concentrates; written/paper submission and in the
represent the current thinking of FDA Guidance for Industry.’’ The guidance manner detailed (see ‘‘Written/Paper
on developing drugs and biologics for document provides establishments that Submissions’’ and ‘‘Instructions’’).
VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1](https://thefederalregister.org/doc/81_FR_82002/page/1.svg)
![81780 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
Written/Paper Submissions regulatoryinformation/dockets/ This guidance is being issued
default.htm. consistent with FDA’s good guidance
Submit written/paper submissions as Docket: For access to the docket to practices regulation (21 CFR 10.115).
follows: read background documents or the FDA is issuing this guidance for
• Mail/Hand delivery/Courier (for electronic and written/paper comments immediate implementation in
written/paper submissions): Division of received, go to http:// accordance with 21 CFR 10.115(g)(2)
Dockets Management (HFA–305), Food www.regulations.gov and insert the without initially seeking prior comment
and Drug Administration, 5630 Fishers docket number, found in brackets in the because the Agency has determined that
Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the prior public participation is not
• For written/paper comments ‘‘Search’’ box and follow the prompts appropriate. This guidance recommends
submitted to the Division of Dockets and/or go to the Division of Dockets a less burdensome policy that is
Management, FDA will post your Management, 5630 Fishers Lane, Rm. consistent with the public health. The
comment, as well as any attachments, 1061, Rockville, MD 20852. guidance represents the current thinking
except for information submitted, Submit written requests for single of FDA on ‘‘Revised Recommendations
marked and identified, as confidential, copies of the guidance to the Office of for Determining Eligibility of Donors of
if submitted as detailed in Communication, Outreach and Human Cells, Tissues, and Cellular and
‘‘Instructions.’’ Development, Center for Biologics Tissue-Based Products Who Have
Instructions: All submissions received Evaluation and Research (CBER), Food Received Human-Derived Clotting
must include the Docket No. FDA– and Drug Administration, 10903 New Factor Concentrates.’’ It does not
2016–D–3750 for ‘‘Revised Hampshire Ave., Bldg. 71, Rm. 3128, establish any rights for any person and
Recommendations for Determining Silver Spring, MD 20993–0002. Send is not binding on FDA or the public.
Eligibility of Donors of Human Cells, one self-addressed adhesive label to You can use an alternative approach if
Tissues, and Cellular and Tissue-Based assist the office in processing your it satisfies the requirements of the
Products Who Have Received Human- requests. The guidance may also be applicable statutes and regulations.
Derived Clotting Factor Concentrates; obtained by mail by calling CBER at 1–
II. Paperwork Reduction Act of 1995
Guidance for Industry.’’ Received 800–835–4709 or 240–402–8010. See
comments will be placed in the docket the SUPPLEMENTARY INFORMATION section This guidance refers to previously
and, except for those submitted as for electronic access to the guidance approved collections of information
‘‘Confidential Submissions,’’ publicly document. found in FDA regulations. These
viewable at http://www.regulations.gov collections of information are subject to
FOR FURTHER INFORMATION CONTACT:
or at the Division of Dockets review by the Office of Management and
Melissa Segal, Center for Biologics
Management between 9 a.m. and 4 p.m., Budget (OMB) under the Paperwork
Evaluation and Research, Food and
Monday through Friday. Reduction Act of 1995 (44 U.S.C. 3501–
Drug Administration, 10903 New
3520). The collections of information in
• Confidential Submissions—To Hampshire Ave., Bldg. 71, Rm. 7301,
21 CFR 1271.47 have been approved
submit a comment with confidential Silver Spring, MD 20993–0002, 240–
under OMB control number 0910–0543.
information that you do not wish to be 402–7911.
made publicly available, submit your SUPPLEMENTARY INFORMATION: III. Electronic Access
comments only as a written/paper Persons with access to the Internet
submission. You should submit two I. Background
may obtain the guidance at either http://
copies total. One copy will include the FDA is announcing the availability of www.fda.gov/BiologicsBloodVaccines/
information you claim to be confidential a document entitled ‘‘Revised GuidanceComplianceRegulatory
with a heading or cover note that states Recommendations for Determining Information/Guidances/default.htm or
‘‘THIS DOCUMENT CONTAINS Eligibility of Donors of Human Cells, http://www.regulations.gov.
CONFIDENTIAL INFORMATION.’’ The Tissues, and Cellular and Tissue-Based
Dated: November 14, 2016.
Agency will review this copy, including Products Who Have Received Human-
the claimed confidential information, in Derived Clotting Factor Concentrates; Leslie Kux,
its consideration of comments. The Guidance for Industry.’’ The guidance Associate Commissioner for Policy.
second copy, which will have the document provides establishments that [FR Doc. 2016–27768 Filed 11–17–16; 8:45 am]
claimed confidential information make DE determinations for donors of BILLING CODE 4164–01–P
redacted/blacked out, will be available HCT/Ps with information on infectious
for public viewing and posted on http:// disease risks related to receipt of
www.regulations.gov. Submit both HDCFCs. The guidance explains that DEPARTMENT OF HEALTH AND
copies to the Division of Dockets FDA no longer considers FDA licensed HUMAN SERVICES
Management. If you do not wish your HDCFCs as a risk factor for HIV, HBV,
Food and Drug Administration
name and contact information to be or HCV. As such, receipt of FDA
made publicly available, you can licensed HDCFCs, or sex with a person [Docket No. FDA–2016–N–3680]
provide this information on the cover who has received FDA licensed
sheet and not in the body of your HDCFCs, should not be considered a Determination That BENEMID
comments and you must identify this risk factor when determining eligibility (Probenecid) Tablet and Other Drug
information as ‘‘confidential.’’ Any of a donor of HCT/Ps. The Products Were Not Withdrawn From
information marked as ‘‘confidential’’ recommendations in the guidance Sale for Reasons of Safety or
mstockstill on DSK3G9T082PROD with NOTICES
will not be disclosed except in supersede the recommendations Effectiveness
accordance with 21 CFR 10.20 and other contained in section IV.E.3. of the AGENCY: Food and Drug Administration,
applicable disclosure law. For more guidance entitled ‘‘Eligibility HHS.
information about FDA’s posting of Determination for Donors of Human ACTION: Notice.
comments to public dockets, see 80 FR Cells, Tissues, and Cellular and Tissue-
56469, September 18, 2015, or access Based Products (HCT/Ps); Guidance for SUMMARY: The Food and Drug
the information at: http://www.fda.gov/ Industry’’ dated August 2007. Administration (FDA or Agency) has
VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1](https://thefederalregister.org/doc/81_FR_82002/page/2.svg)
Document Created: 2018-02-14 08:31:26
Document Modified: 2018-02-14 08:31:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 81779 |
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