Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period, 65322-65323 [2018-27519]

Download as PDF 65322 § 61.155 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules Aeronautical knowledge. * * * * * (c) * * * (14) For an airplane category multiengine class rating, the content of the airline transport pilot certification training program in § 61.156. ■ 6. Amend § 61.156 by revising the heading and introductory text to read as follows: § 61.156 Training requirements: Airplane category—multiengine class or multiengine airplane type rating concurrently with an airline transport pilot certificate. A person who applies for the knowledge test for an airline transport pilot certificate with an airplane category multiengine class rating must present a graduation certificate from an authorized training provider under part 121, 135, 141, or 142 of this chapter certifying the applicant has completed the following training in a course approved by the Administrator. * * * * * ■ 7. Amend § 61.160 by revising the introductory text of paragraph (a), the introductory text of paragraph (b), the introductory text of paragraph (c), and paragraph (d) to read as follows: khammond on DSK30JT082PROD with PROPOSAL § 61.160 Aeronautical experience— airplane category restricted privileges. (a) Except for a person who has been removed from flying status for lack of proficiency or because of a disciplinary action involving aircraft operations, a U.S. military pilot or former U.S. military pilot may apply for an airline transport pilot certificate with an airplane category multiengine class rating or an airline transport pilot certificate concurrently with a multiengine airplane type rating with a minimum of 750 hours of total time as a pilot if the pilot presents: * * * * * (b) A person may apply for an airline transport pilot certificate with an airplane category multiengine class rating or an airline transport pilot certificate concurrently with a multiengine airplane type rating with a minimum of 1,000 hours of total time as a pilot if the person: * * * * * (c) A person may apply for an airline transport pilot certificate with an airplane category multiengine class rating or an airline transport pilot certificate concurrently with a multiengine airplane type rating with a minimum of 1,250 hours of total time as a pilot if the person: * * * * * (d) A graduate of an institution of higher education who completes fewer than 60 semester credit hours but at VerDate Sep<11>2014 16:45 Dec 19, 2018 Jkt 247001 least 30 credit hours and otherwise satisfies the requirements of paragraph (b) may apply for airline transport pilot certificate with an airplane category multiengine class rating or an airline transport pilot certificate concurrently with a multiengine airplane type rating with a minimum of 1,250 hours of total time as a pilot. * * * * * ■ 8. Amend § 61.165 by revising paragraph (c)(2), the introductory text of paragraph (f), and paragraph (f)(2) to read as follows: § 61.165 Additional aircraft category and class ratings. * * * * * (c) * * * (2) Successfully complete the airline transport pilot certification training program specified in § 61.156; * * * * * (f) Adding a multiengine class rating to an airline transport pilot certificate with a single engine class rating. A person applying to add a multiengine class rating, or a multiengine class rating concurrently with a multiengine airplane type rating, to an airline transport pilot certificate with an airplane category single engine class rating must— * * * (2) Pass a required knowledge test on the aeronautical knowledge areas of § 61.155(c), as applicable to multiengine airplanes; * * * * * Issued under authority provided by 49 U.S.C. 106(f), 44701(a)(5), and 44703(a) in Washington, DC, on December 13, 2018. Rick Domingo, Executive Director, Flight Standards Service. [FR Doc. 2018–27402 Filed 12–19–18; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 50, 312, and 812 [Docket No. FDA–2018–N–2727] RIN 0910–AH52 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period. ACTION: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the proposed rule published November 15, 2018 (83 FR 57378). Submit either electronic or written comments by February 13, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 13, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: 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’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and E:\FR\FM\20DEP1.SGM 20DEP1 khammond on DSK30JT082PROD with PROPOSAL Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2018–N–2727 for ‘‘Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. 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 Dockets Management VerDate Sep<11>2014 16:45 Dec 19, 2018 Jkt 247001 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1127. In the Federal Register of November 15, 2018, FDA published a proposed rule with a 60-day comment period to implement the statutory changes made to the Federal Food, Drug, and Cosmetic Act by section 3024 of the 21st Century Cures Act (Pub. L. 114–255) to allow for a waiver or alteration of informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain minimal risk clinical investigations. Comments on the proposed rule will inform FDA’s rulemaking to establish regulations for IRB waiver or alteration of informed consent for certain minimal risk clinical investigations. The Agency has received a request for a 60-day extension of the comment period for the proposed rule. This request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the request and is extending the comment period for the proposed rule for 30 days, until February 13, 2019. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. SUPPLEMENTARY INFORMATION: Dated: December 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–27519 Filed 12–19–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 65323 DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 199 [DOD–2018–HA–0028] RIN 0720–AB72 TRICARE; Addition of Physical Therapy Assistants and Occupational Therapy Assistants as TRICAREAuthorized Providers Office of the Secretary, Department of Defense (DoD). ACTION: Proposed rule. AGENCY: The Department of Defense is publishing this proposed rule to add certified or licensed physical therapy assistants (PTAs) and occupational therapy assistants (OTAs) as TRICAREauthorized providers to engage in physical therapy or occupational therapy under the supervision of a TRICARE-authorized physical therapist or occupational therapist in accordance with Medicare’s rules for supervision and qualification when billed by under the supervising therapist’s national provider identification number. This rule will align TRICARE with Medicare’s policy, which permits PTAs or OTAs to provide physical or occupational therapy when supervised by and billed under a licensed or certified physical therapist or occupational therapist. DATES: Written comments received at the address indicated in the ADDRESSES section by February 19, 2019 will be accepted. SUMMARY: You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) number and title, by either of the following methods: • Federal Rulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, Regulatory and Advisory Committee Division, 4800 Mark Center Drive, Mailbox #24, Suite 08D09, Alexandria, VA 22350–1700. Instructions: All submissions received must include the agency name and docket number or RIN for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at https:// www.regulations.gov as they are received without change, including any ADDRESSES: E:\FR\FM\20DEP1.SGM 20DEP1

Agencies

[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Proposed Rules]
[Pages 65322-65323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27519]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 312, and 812

[Docket No. FDA-2018-N-2727]
RIN 0910-AH52


Institutional Review Board Waiver or Alteration of Informed 
Consent for Minimal Risk Clinical Investigations; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the proposed rule that appeared in the 
Federal Register of November 15, 2018. The Agency is taking this action 
in response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published November 15, 2018 (83 FR 57378). Submit either electronic or 
written comments by February 13, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 13, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 13, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and

[[Page 65323]]

Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-2727 for ``Institutional Review Board Waiver or Alteration 
of Informed Consent for Minimal Risk Clinical Investigations.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-1127.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 15, 
2018, FDA published a proposed rule with a 60-day comment period to 
implement the statutory changes made to the Federal Food, Drug, and 
Cosmetic Act by section 3024 of the 21st Century Cures Act (Pub. L. 
114-255) to allow for a waiver or alteration of informed consent when a 
clinical investigation poses no more than minimal risk to the human 
subject and includes appropriate safeguards to protect the rights, 
safety, and welfare of human subjects. The proposed rule, if finalized, 
would permit an institutional review board (IRB) to waive or alter 
certain informed consent elements or to waive the requirement to obtain 
informed consent, under limited conditions, for certain minimal risk 
clinical investigations. Comments on the proposed rule will inform 
FDA's rulemaking to establish regulations for IRB waiver or alteration 
of informed consent for certain minimal risk clinical investigations.
    The Agency has received a request for a 60-day extension of the 
comment period for the proposed rule. This request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the request and is extending the comment period 
for the proposed rule for 30 days, until February 13, 2019. The Agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

    Dated: December 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27519 Filed 12-19-18; 8:45 am]
 BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.