81 FR 23664 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 78 (April 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 78 (April 22, 2016)
| Page Range | 23664-23666 | |
| FR Document | 2016-09366 |
[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)] [Proposed Rules] [Pages 23664-23666] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09366] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket Nos. FDA-2014-D-1584, FDA-2014-D-1696, FDA-2014-D-1856, and FDA-2015-D-3581] Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS. ACTION: Notification; extension of comment periods. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled ``Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry''; ``Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry''; and ''Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' The Agency is taking this action to allow interested persons additional time to submit comments and any new information. DATES: FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION). Submit either electronic or written comments by September 27, 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 [[Page 23665]] 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-1584 for ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry''; 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''; Docket No. FDA-2014-D-1856 for ``Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry''; or Docket No. FDA-2015- D-3581 for ``Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.'' 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. FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240- 402-7911, [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of October 23, 2014 (79 FR 63348), FDA announced the availability of a draft document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry'' dated October 2014. 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. In the Federal Register of December 24, 2014 (79 FR 77414), FDA announced the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. Following publication of these three notices of availability, FDA received requests to allow interested persons additional time to comment. In the Federal Register of October 30, 2015 (80 FR 66850), FDA announced 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'' dated October 2015. In the Federal Register of October 30, 2015 (80 FR 66845), FDA announced a public hearing in a notice entitled ``Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments''. The draft guidances on same surgical procedure, minimal manipulation, adipose tissue, and homologous use provide recommendations for complying with the regulatory framework for human cells, tissues, and cellular and tissue based products under 21 CFR part 1271 that were to be discussed during the part 15 (21 CFR part 15) hearing. In conjunction with the part 15 hearing and announcement of availability of the homologous use draft guidance, in the Federal Register of October 30, 2015 (80 FR 66847; 80 FR 66844; 80 FR 66849), FDA reopened the comment periods on the same surgical procedure, minimal manipulation, and adipose tissue draft guidances, respectively, to allow potential respondents time to thoroughly evaluate and address pertinent issues. Comments were requested by April 29, 2016. In this notice FDA is extending the comment period to September 27, 2016. Elsewhere in this issue of the Federal Register, FDA is announcing the rescheduling of a 2-day part 15 public hearing to September 12 and 13, 2016, to obtain input from stakeholders on the four issued draft guidance documents. In a separate document, FDA is also announcing a public scientific workshop to identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products subject to premarket approval, including stem cell-based products. [[Page 23666]] Dated: April 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09366 Filed 4-21-16; 8:45 am] BILLING CODE 4164-01-P
![23664 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Proposed Rules
public hearing must register at https:// public hearing will be available at the DEPARTMENT OF HEALTH AND
www.eventbrite.com/e/part-15-hearing- same Web address for 1 year. HUMAN SERVICES
on-draft-guidances-relating-to-the-
regulation-of-hctps-registration- V. Notice of Hearing Under 21 CFR Part Food and Drug Administration
22921962206 on or before June 1, 2016. 15
Persons who wish to attend and speak 21 CFR Part 1271
The Commissioner of Food and Drugs
at the public hearing will be required to is announcing that the public hearing [Docket Nos. FDA–2014–D–1584, FDA–
provide complete contact information, 2014–D–1696, FDA–2014–D–1856, and FDA–
will be held in accordance with part 15
including name, title, affiliation, email, 2015–D–3581]
(21 CFR part 15). The hearing will be
and phone number. To help FDA
conducted by a presiding officer, who Draft Guidances Relating to the
organize the presentations, persons who
wish to attend and speak must also will be accompanied by FDA senior Regulation of Human Cells, Tissues,
indicate whether they are speaking on management from the Office of the and Cellular and Tissue-Based
their own behalf or on behalf of an Commissioner and the Center for Products; Extension of Comment
organization. If speaking on behalf of an Biologics Evaluation and Research. Periods
organization, the name of the Under § 15.30(f), the hearing is AGENCY: Food and Drug Administration,
organization must be provided. Persons informal and the rules of evidence do HHS.
who wish to attend and speak must also not apply. No participant may interrupt
indicate if they will be speaking on the Notification; extension of
ACTION:
the presentation of another participant. comment periods.
draft guidance documents. Individuals Only the presiding officer and panel
and organizations with common members may question any person SUMMARY: The Food and Drug
interests should consolidate or during or at the conclusion of each Administration (FDA or the Agency) is
coordinate their presentations and presentation. Public hearings under part extending the comment period for the
request time for a joint presentation. 15 are subject to FDA’s policy and draft guidance documents entitled
There will be no open public session at procedures for electronic media ‘‘Same Surgical Procedure Exception:
the public hearing. coverage of FDA’s public administrative Questions and Answers Regarding the
FDA will do its best to accommodate proceedings (21 CFR part 10, subpart C). Scope of the Exception; Draft Guidance
requests to speak at the public hearing Under § 10.205, representatives of the for Industry’’; ‘‘Minimal Manipulation
and will determine the amount of time of Human Cells, Tissues, and Cellular
electronic media may be permitted,
allotted for each oral presentation, and and Tissue-Based Products; Draft
subject to certain limitations, to
the approximate time that each oral Guidance for Industry and Food and
presentation will be scheduled to begin. videotape, film, or otherwise record
FDA’s public administrative Drug Administration Staff’’; ‘‘Human
Multiple speakers from the same Cells, Tissues, and Cellular and Tissue-
organization will be given one proceedings, including presentations by
Based Products from Adipose Tissue:
presentation slot for that organization. If participants. The hearing will be
Regulatory Considerations; Draft
the number of persons or organizations transcribed as stipulated in § 15.30(b) Guidance for Industry’’; and
requesting to speak is greater than can (see section VI of this document). To the ’’Homologous Use of Human Cells,
be reasonably accommodated, FDA will extent that the conditions for the Tissues, and Cellular and Tissue-Based
close registration for speakers. FDA will hearing, as described in this notice, Products; Draft Guidance for Industry
notify registered speakers of their conflict with any provisions set out in and FDA Staff.’’ The Agency is taking
scheduled times, and make available an part 15, this notice acts as a waiver of this action to allow interested persons
agenda at http://www.fda.gov/ those provisions as specified in additional time to submit comments and
BiologicsBloodVaccines/NewsEvents/ § 15.30(h). any new information.
WorkshopsMeetingsConferences/ DATES: FDA is extending the comment
ucm462125.htm on or before July 1, VI. Transcripts
period on the four draft guidances
2016. Once FDA notifies registered Please be advised that as soon as a announced in the Federal Register (see
speakers of their scheduled times, transcript is available, it will be SUPPLEMENTARY INFORMATION). Submit
presenters should submit an electronic accessible at www.regulations.gov and either electronic or written comments
copy of their presentation to http://www.fda.gov/ by September 27, 2016.
CBERPublicEvents@fda.hhs.gov by ADDRESSES: You may submit comments
BiologicsBloodVaccines/NewsEvents/
August 1, 2016. as follows:
WorkshopsMeetingsConferences/
If you need special accommodations
ucm462125.htm. It may be viewed at the Electronic Submissions
because of a disability, please contact
Division of Dockets Management (see
Sherri Revell or Loni Warren Henderson Submit electronic comments in the
ADDRESSES). A transcript will also be
at 240–402–8010 at least 7 days before following way:
available in either hardcopy or on CD–
the hearing. • Federal eRulemaking Portal: http://
A link to the live Webcast of this ROM, after submission of a Freedom of www.regulations.gov. Follow the
public hearing will be available at Information request. The Freedom of instructions for submitting comments.
http://www.fda.gov/ Information office address is available Comments submitted electronically,
BiologicsBloodVaccines/NewsEvents/ on the Agency’s Web site at http:// including attachments, to http://
mstockstill on DSK4VPTVN1PROD with PROPOSALS
WorkshopsMeetingsConferences/ www.fda.gov. www.regulations.gov will be posted to
ucm462125.htm on the day of the public Dated: April 19, 2016. the docket unchanged. Because your
hearing. A video record of the public Leslie Kux, comment will be made public, you are
hearing will be available at http:// solely responsible for ensuring that your
Associate Commissioner for Policy.
www.fda.gov/BiologicsBloodVaccines/ comment does not include any
[FR Doc. 2016–09372 Filed 4–21–16; 8:45 am]
NewsEvents/ confidential information that you or a
WorkshopsMeetingsConferences/ BILLING CODE 4164–01–P third party may not wish to be posted,
ucm462125.htm. A video record of the such as medical information, your or
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![23666 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Proposed Rules
Dated: April 19, 2016. http://www2.epa.gov/dockets/ The proposed rule would enable the
Leslie Kux, commenting-epa-dockets. BLM to more readily address landscape-
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: Zuri scale resource issues, such as wildfire,
[FR Doc. 2016–09366 Filed 4–21–16; 8:45 am] Farngalo or D. Brad Akers, Air habitat connectivity, or the demand for
BILLING CODE 4164–01–P Regulatory Management Section, Air renewable and non-renewable energy
Planning and Implementation Branch, sources and to respond more effectively
Air, Pesticides and Toxics Management to environmental and social changes.
Division, U.S. Environmental Protection The proposed rule would further
ENVIRONMENTAL PROTECTION Agency, Region 4, 61 Forsyth Street emphasize the role of science in the
AGENCY SW., Atlanta, Georgia 30303–8960. Mr. planning process and the importance of
Farngalo can be reached at (404) 562– evaluating the resource, environmental,
40 CFR Part 52 ecological, social, and economic
9152 and via electronic mail at
farngalo.zuri@epa.gov. Mr. Akers can be conditions at the onset of planning. The
[EPA–R04–OAR–2015–0618; FRL–9945–21– proposed rule would affirm the
Region 4] reached at (404) 562–9089 and via
electronic mail at akers.brad@epa.gov. important role of other Federal agencies,
Air Plan Approval: Tennessee: Knox State and local governments, Indian
SUPPLEMENTARY INFORMATION: In the
County VOC Limits Revision for tribes, and the public during the
Rules and Regulations section of this planning process, and would enhance
Permits issue of the Federal Register, EPA is opportunities for public involvement
approving the State’s implementation and transparency during the preparation
AGENCY: Environmental Protection
plan revision as a direct final rule of resource management plans. Finally,
Agency.
without prior proposal because the the proposed rule would make revisions
ACTION: Proposed rule. Agency views this as a noncontroversial to clarify existing text and use plain
SUMMARY: The Environmental Protection submittal and anticipates no adverse language to improve the readability of
Agency (EPA) is proposing to approve a comments. A detailed rationale for the the planning regulations. This notice
portion of a State Implementation Plan approval is set forth in the direct final extends the public comment period for
(SIP) revision submitted by the State of rule. If no adverse comments are 30 days beyond the initial comment-
Tennessee, submitted on March 14, received in response to this rule, no period deadline.
2014, through the Tennessee further activity is contemplated. If EPA
DATES: Send your comments on this
Department of Environmental receives adverse comments, the direct
final rule will be withdrawn and all proposed rule to the BLM on or before
Conservation on behalf of the Knox May 25, 2016. The BLM need not
County Department of Air Quality public comments received will be
addressed in a subsequent final rule consider, or include in the
Management (Knox County) to address administrative record for the final rule,
changes to a Knox County regulation based on this proposed rule. EPA will
not institute a second comment period comments that the BLM receives after
regarding permits. EPA is proposing to the close of the comment period or
approve this SIP revision because the on this document. Any parties
interested in commenting on this comments delivered to an address other
State has demonstrated that it is than those listed below (see ADDRESSES).
consistent with the Clean Air Act. document should do so at this time.
ADDRESSES: Mail: U.S. Department of
DATES: Written comments must be Dated: April 6, 2016. the Interior, Director (630), Bureau of
received on or before May 23, 2016. Heather McTeer Toney, Land Management, Mail Stop 2134 LM,
ADDRESSES: Submit your comments, Regional Administrator, Region 4. 1849 C St. NW., Washington, DC 20240,
identified by Docket ID No. EPA–R04– [FR Doc. 2016–09160 Filed 4–21–16; 8:45 am] Attention: 1004–AE39. Personal or
OAR–2015–0618 at http:// BILLING CODE 6560–50–P messenger delivery: Bureau of Land
www.regulations.gov. Follow the online Management, 20 M Street SE., Room
instructions for submitting comments. 2134 LM, Attention: Regulatory Affairs,
Once submitted, comments cannot be DEPARTMENT OF THE INTERIOR Washington, DC 20003. Federal
edited or removed from Regulations.gov. eRulemaking Portal: http://
EPA may publish any comment received Bureau of Land Management www.regulations.gov. Follow the
to its public docket. Do not submit instructions at this Web site.
electronically any information you 43 CFR Part 1600 FOR FURTHER INFORMATION CONTACT:
consider to be Confidential Business [LLWO210000.16X.L16100000.PN0000] Leah Baker, Division Chief, Decision
Information (CBI) or other information Support, Planning and NEPA, at 202–
whose disclosure is restricted by statute. RIN 1004–AE39 912–7282, for information relating to the
Multimedia submissions (audio, video, BLM’s national planning program or the
Resource Management Planning
etc.) must be accompanied by a written substance of this proposed rule. For
comment. The written comment is AGENCY: Bureau of Land Management, information on procedural matters or
considered the official comment and Interior. the rulemaking process, you may
should include discussion of all points ACTION: Proposed rule; extension of contact Charles Yudson at 202–912–
you wish to make. EPA will generally public comment period. 7437. Persons who use a
not consider comments or comment telecommunications device for the deaf
mstockstill on DSK4VPTVN1PROD with PROPOSALS
contents located outside of the primary SUMMARY: On February 25, 2016, the (TDD) may call the Federal Information
submission (i.e., on the web, cloud, or Bureau of Land Management (BLM) Relay Service (FIRS) at 1–800–877–8339
other file sharing system). For published in the Federal Register a to contact the above individuals during
additional submission methods, the full proposed rule to amend existing normal business hours. FIRS is available
EPA public comment policy, regulations that establish the procedures 24 hours a day, 7 days a week to leave
information about CBI or multimedia used to prepare, revise, or amend land a message or question with the above
submissions, and general guidance on use plans pursuant to the Federal Land individuals. You will receive a reply
making effective comments, please visit Policy and Management Act (FLPMA). during normal business hours.
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Document Created: 2017-08-22 23:36:27
Document Modified: 2017-08-22 23:36:27
| 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; extension of comment periods. | |
| Dates | FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION). Submit either electronic or written comments by September 27, 2016. | |
| Contact | Lori Jo Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240- 402-7911, [email protected] | |
| FR Citation | 81 FR 23664 |
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