80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66844-66845 | |
| FR Document | 2015-27705 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Proposed Rules] [Pages 66844-66845] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27705] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. FDA-2014-D-1696] Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,'' published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information. DATES: Submit either electronic or written comments on the draft guidance by April 29, 2016. 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''). 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-2014-D-1696 for ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening the Comment Period.'' 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 [[Page 66845]] 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. FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, 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 In the Federal Register of December 23, 2014 (79 FR 77012), FDA announced the availability of a draft document entitled ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff'' dated December 2014. The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff with recommendations for meeting the 21 CFR 1271.10(a)(1) criterion of minimal manipulation. Interested persons were originally given until February 23, 2015, to comment on the draft guidance. Elsewhere in this issue of the Federal Register, FDA is announcing four other related documents. In a separate document, FDA is announcing a public hearing entitled ``Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments'' (part 15 hearing) to be held on April 13, 2016, to provide stakeholders with the opportunity to discuss FDA's policy on regulation of HCT/Ps related to the four draft guidances on the following topics: Homologous use, same surgical procedure exception, minimal manipulation, and adipose tissue. In a separate document, FDA is announcing the availability of a draft document entitled ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' In separate documents, FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents on the following topics related to HCT/Ps: Adipose tissue (Docket No. FDA-2014-D-1856) and same surgical procedure exception (Docket No. FDA- 2014-D-1584). II. Reopening of Comment Period Following publication of December 23, 2014, notice of availability, FDA received a request to allow interested persons additional time to comment. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, FDA is reopening the comment period to allow potential respondents to thoroughly evaluate and address pertinent issues. The minimal manipulation draft guidance and other related guidances (homologous use, same surgical procedure exception, adipose tissue) all deal with the interpretation of the regulations under 21 CFR part 1271 that will be addressed as part of the part 15 hearing. Dated: October 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27705 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
![66844 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules
Clearance, Social Security DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
Administration, 3100 West High Rise, HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
6401 Security Boulevard, Baltimore, Written/Paper Submissions
Maryland 21235–6401. Food and Drug Administration
Submit written/paper submissions as
Comments are available for public follows:
21 CFR Part 1271
viewing on the Federal eRulemaking • Mail/Hand delivery/Courier (for
portal at http://www.regulations.gov or [Docket No. FDA–2014–D–1696] written/paper submissions): Division of
in person, during regular business Dockets Management (HFA–305), Food
hours, by arranging with the contact Minimal Manipulation of Human Cells, and Drug Administration, 5630 Fishers
person identified below. Tissues, and Cellular and Tissue- Lane, Rm. 1061, Rockville, MD 20852.
Based Products; Draft Guidance for • For written/paper comments
FOR FURTHER INFORMATION CONTACT: Industry and Food and Drug submitted to the Division of Dockets
Mary Quatroche, Office of Disability Administration Staff; Reopening of the Management, FDA will post your
Policy, Social Security Administration, Comment Period comment, as well as any attachments,
6401 Security Boulevard, Baltimore, MD except for information submitted,
21235–6401, (410) 966–4794. For AGENCY: Food and Drug Administration,
HHS. marked and identified, as confidential,
information on eligibility or filing for if submitted as detailed in
benefits, call our national toll-free Notification; reopening of the
ACTION: ‘‘Instructions.’’
number, 1–800–772–1213 or TTY 1– comment period. Instructions: All submissions received
800–325–0778, or visit our Internet site, must include the Docket No. FDA–
SUMMARY: The Food and Drug
Social Security Online, at http:// 2014–D–1696 for ‘‘Minimal
Administration (FDA) is reopening the
www.socialsecurity.gov. Manipulation of Human Cells, Tissues,
comment period for the draft document
and Cellular and Tissue-Based Products;
SUPPLEMENTARY INFORMATION: This entitled ‘‘Minimal Manipulation of
Draft Guidance for Industry and Food
document extends the comment period Human Cells, Tissues, and Cellular and
and Drug Administration Staff;
Tissue-Based Products; Draft Guidance
to Monday, December 14, 2015, for the Reopening the Comment Period.’’
for Industry and Food and Drug Received comments will be placed in
advanced notice of proposed
Administration Staff,’’ published in the the docket and, except for those
rulemaking that we published on
Federal Register of December 23, 2014. submitted as ‘‘Confidential
September 14, 2015. We are extending FDA is reopening the comment period
the comment period in light of the Submissions,’’ publicly viewable at
to allow interested persons additional http://www.regulations.gov or at the
comments we anticipate receiving from time to submit comments and any new
our National Disability Forum occurring Division of Dockets Management
information. between 9 a.m. and 4 p.m., Monday
on November 20, 2015, which includes
DATES: Submit either electronic or through Friday.
a panel discussion on the topic of our written comments on the draft guidance • Confidential Submissions—To
vocational factors. If you have already by April 29, 2016. submit a comment with confidential
provided comments on the proposed information that you do not wish to be
ADDRESSES: You may submit comments
rules, we will consider your comments made publicly available, submit your
as follows:
and you do not need to resubmit them. comments only as a written/paper
Electronic Submissions submission. You should submit two
Social Security Administration—
National Disability Forum Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
Friday, November 20, 2015, 1:00 p.m.– • Federal eRulemaking Portal: http:// with a heading or cover note that states
3:00 p.m., National Education www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Association, 1201 16th Street NW., instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
Washington, DC 20036 Comments submitted electronically, Agency will review this copy, including
including attachments, to http:// the claimed confidential information, in
Speakers www.regulations.gov will be posted to its consideration of comments. The
• Paul Van de Water—Center on Budget the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
and Policy Priorities—Moderator
solely responsible for ensuring that your redacted/blacked out, will be available
• Kate Lang—Justice in Aging comment does not include any for public viewing and posted on http://
• Rebecca Vallas—Center for American confidential information that you or a www.regulations.gov. Submit both
Progress third party may not wish to be posted, copies to the Division of Dockets
such as medical information, your or Management. If you do not wish your
• Mark Warshawsky—Mercatus Center
anyone else’s Social Security number, or name and contact information to be
at George Mason University
confidential business information, such made publicly available, you can
• Ross Eisenbrey—Economic Policy as a manufacturing process. Please note provide this information on the cover
Institute that if you include your name, contact sheet and not in the body of your
• Kim Hildred—Hildred Consulting, information, or other information that comments and you must identify this
tkelley on DSK3SPTVN1PROD with PROPOSALS
LLC identifies you in the body of your information as ‘‘confidential’’. Any
comments, that information will be information marked as ‘‘confidential’’
Carolyn W. Colvin, posted on http://www.regulations.gov. will not be disclosed except in
Acting Commissioner of Social Security. • If you want to submit a comment accordance with 21 CFR 10.20 and other
[FR Doc. 2015–27692 Filed 10–29–15; 8:45 am] with confidential information that you applicable disclosure law. For more
BILLING CODE 4191–02–P do not wish to be made available to the information about FDA’s posting of
public, submit the comment as a comments to public dockets, see 80 FR
written/paper submission and in the 56469, September 18, 2015, or access
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![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Proposed Rules 66845
the information at: http://www.fda.gov/ issued draft guidance documents on the DATES: The public hearing will be held
regulatoryinformation/dockets/ following topics related to HCT/Ps: on April 13, 2016, from 8 a.m. to 5 p.m.
default.htm. Adipose tissue (Docket No. FDA–2014– The meeting may be extended or end
Docket: For access to the docket to D–1856) and same surgical procedure early depending on the level of public
read background documents or the exception (Docket No. FDA–2014–D– participation. Persons seeking to attend
electronic and written/paper comments 1584). or to present at the public hearing must
received, go to http:// register by January 8, 2016. Section IV
II. Reopening of Comment Period
www.regulations.gov and insert the provides attendance and registration
docket number, found in brackets in the Following publication of December information. Electronic or written
heading of this document, into the 23, 2014, notice of availability, FDA comments will be accepted after the
‘‘Search’’ box and follow the prompts received a request to allow interested public hearing until April 29, 2016.
and/or go to the Division of Dockets persons additional time to comment. In ADDRESSES: The public hearing will be
Management, 5630 Fishers Lane, Rm. conjunction with the part 15 hearing held at FDA’s White Oak Campus,
1061, Rockville, MD 20852. and announcement of availability of the 10903 New Hampshire Ave., Bldg. 31
homologous use draft guidance, FDA is Conference Center, the Great Room (Rm.
FOR FURTHER INFORMATION CONTACT: Lori
reopening the comment period to allow 1503), Silver Spring, MD 20993.
J. Churchyard, Center for Biologics
potential respondents to thoroughly Entrance for the public hearing
Evaluation and Research, Food and
evaluate and address pertinent issues. participants (non-FDA employees) is
Drug Administration, 10903 New
The minimal manipulation draft through Building 1, where routine
Hampshire Ave., Bldg. 71, Rm. 7301,
guidance and other related guidances security check procedures will be
Silver Spring, MD 20993–0002, 240–
(homologous use, same surgical performed. For parking and security
402–7911.
procedure exception, adipose tissue) all information, please refer to http://
SUPPLEMENTARY INFORMATION: deal with the interpretation of the www.fda.gov/aboutfda/workingatfda/
I. Background regulations under 21 CFR part 1271 that buildingsandfacilities/
will be addressed as part of the part 15 whiteoakcampusinformation/
In the Federal Register of December hearing.
23, 2014 (79 FR 77012), FDA announced ucm241740.htm.
the availability of a draft document Dated: October 27, 2015. You may submit comments as
entitled ‘‘Minimal Manipulation of Leslie Kux, follows:
Human Cells, Tissues, and Cellular and Associate Commissioner for Policy. Electronic Submissions
Tissue-Based Products; Draft Guidance [FR Doc. 2015–27705 Filed 10–29–15; 8:45 am]
Submit electronic comments in the
for Industry and Food and Drug BILLING CODE 4164–01–P
following way:
Administration Staff’’ dated December • Federal eRulemaking Portal: http://
2014. The draft guidance document www.regulations.gov. Follow the
provides human cells, tissues, and DEPARTMENT OF HEALTH AND
HUMAN SERVICES instructions for submitting comments.
cellular and tissue-based product (HCT/ Comments submitted electronically,
P) manufacturers, health care providers, including attachments, to http://
and FDA staff with recommendations Food and Drug Administration
www.regulations.gov will be posted to
for meeting the 21 CFR 1271.10(a)(1) the docket unchanged. Because your
21 CFR Part 1271
criterion of minimal manipulation. comment will be made public, you are
Interested persons were originally given [Docket No. FDA–2015–D–3719] solely responsible for ensuring that your
until February 23, 2015, to comment on comment does not include any
the draft guidance. Draft Guidances Relating to the
Regulation of Human Cells, Tissues, or confidential information that you or a
Elsewhere in this issue of the Federal third party may not wish to be posted,
Register, FDA is announcing four other Cellular or Tissue-Based Products;
Public Hearing; Request for Comments such as medical information, your or
related documents. In a separate anyone else’s Social Security number, or
document, FDA is announcing a public AGENCY: Food and Drug Administration, confidential business information, such
hearing entitled ‘‘Draft Guidances HHS. as a manufacturing process. Please note
Relating to the Regulation of Human ACTION: Notification of public hearing; that if you include your name, contact
Cells, Tissues, or Cellular or Tissue- request for comments. information, or other information that
Based Products; Public Hearing; Request identifies you in the body of your
for Comments’’ (part 15 hearing) to be SUMMARY: The Food and Drug comments, that information will be
held on April 13, 2016, to provide Administration (FDA or Agency) is posted on http://www.regulations.gov.
stakeholders with the opportunity to announcing a 1-day public hearing to • If you want to submit a comment
discuss FDA’s policy on regulation of obtain input on four recently issued with confidential information that you
HCT/Ps related to the four draft draft guidances relating to the regulation do not wish to be made available to the
guidances on the following topics: of human cells, tissues, or cellular or public submit the comment as a written/
Homologous use, same surgical tissue-based products (HCT/Ps). These paper submission and in the manner
procedure exception, minimal draft guidances were issued by FDA in detailed (see ‘‘Written/Paper
manipulation, and adipose tissue. response to stakeholders’ requests for Submissions’’ and ‘‘Instructions’’).
In a separate document, FDA is guidance on FDA’s current views about
Written/Paper Submissions
tkelley on DSK3SPTVN1PROD with PROPOSALS
announcing the availability of a draft how manufacturers, establishments, and
document entitled ‘‘Homologous Use of distributors of HCT/Ps and health care Submit written/paper submissions as
Human Cells, Tissues, and Cellular and professionals can meet the criteria follows:
Tissue-Based Products; Draft Guidance under the Agency’s regulations that • Mail/Hand delivery/Courier (for
for Industry and FDA Staff.’’ apply to HCT/Ps. FDA will consider written/paper submissions): Division of
In separate documents, FDA is also information it obtains from the public Dockets Management (HFA–305), Food
reopening the comment periods to hearing in the finalization of these and Drug Administration, 5630 Fishers
FDA’s public dockets on the previously guidances. Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 16:29 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\30OCP1.SGM 30OCP1](https://thefederalregister.org/doc/80_FR_67054/page/2.svg)
Document Created: 2015-12-14 15:30:07
Document Modified: 2015-12-14 15:30:07
| 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 | Proposed Rules | |
| Action | Notification; reopening of the comment period. | |
| Dates | Submit either electronic or written comments on the draft guidance by April 29, 2016. | |
| Contact | Lori J. Churchyard, 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 | 80 FR 66844 |
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