[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27449-27450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10612]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0406]


Frequently Asked Questions--Statement of Investigator (Form FDA 
1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, 
Clinical Investigators, and Institutional Review Boards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft information sheet guidance for 
sponsors, clinical investigators, and institutional review boards 
(IRBs) entitled ``Frequently Asked Questions--Statement of Investigator 
(Form FDA 1572) (Revision 1).'' This draft guidance partially revises 
the final information sheet guidance for sponsors, clinical 
investigators, and IRBs entitled ``Frequently Asked Questions--
Statement of Investigator (Form FDA 1572)'' (May 2010) (the Form FDA 
1572 FAQ Guidance) to explain FDA's current thinking regarding waivers 
of the signature requirement for Form FDA 1572. This draft guidance 
proposes to revise responses to frequently asked questions 10, 11, and 
13 from the Form FDA 1572 FAQ Guidance by including information 
regarding the waiver of the Form FDA 1572 signature requirement and 
proposes a new section regarding signature waivers.

DATES: Submit either electronic or written comments on the draft 
guidance by July 19, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and 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-2008-D-0406 for ``Frequently Asked Questions--Statement of 
Investigator (Form FDA 1572) (Revision 1).'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

[[Page 27450]]


FOR FURTHER INFORMATION CONTACT: Paul Gouge, Center for Drug Evaluation 
and Research, Food and Drug Administration, Bldg. 51, Rm. 6328, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3093, 
paul.gouge@fda.hhs.gov; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft information sheet 
guidance for sponsors, clinical investigators, and IRBs entitled 
``Frequently Asked Questions--Statement of Investigator (Form FDA 1572) 
(Revision 1).'' The draft guidance proposes to revise responses to the 
following questions from the Form FDA 1572 FAQ Guidance:
     Question 10: Must investigators who conduct studies 
outside the United States sign a 1572?
     Question 11: If a foreign clinical study is being 
conducted under an IND [investigational new drug application], what are 
the investigator's responsibilities with respect to regional, national, 
or local laws and regulations?
     Question 13: If a sponsor chooses to conduct a foreign 
clinical study under an IND and the investigators at the non-U.S. sites 
follow the recommendations in the [International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use] ICH E6 Good Clinical Practice Consolidated Guidance, would the 
non-U.S. investigators also be in compliance with FDA's IND 
requirements under 21 CFR part 312?
    The above questions now include reference to the Form FDA 1572 
waiver process. Further, the draft guidance proposes the addition of a 
new section describing the Agency's current thinking regarding the Form 
FDA 1572 signature waiver process. The new section is entitled 
``Section #9: Form FDA 1572 Signature Waiver.'' This new section 
outlines the process for submitting requests to FDA for waivers from 
the Form FDA 1572 signature requirements when investigators cannot or 
will not sign the Form FDA 1572 for clinical studies conducted in 
foreign countries, and the sponsor wishes to conduct the study at the 
foreign sites under an IND. The new section also provides information 
regarding the documentation that may be included in the 1572 signature 
waiver request.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). Based on the comments 
received to the docket, we intend to revise the Form FDA 1572 FAQ 
Guidance to amend our responses to questions (such as general questions 
10, 11, and 13) from that document and to include a new section (see 
questions 39 through 46 of the draft guidance) about waivers of the 
Form FDA 1572 signature requirement, the subjects addressed in this 
draft guidance. This draft guidance is not intended to be finalized as 
a separate guidance document but will be consolidated with the Form FDA 
1572 Guidance and issued as one comprehensive guidance. When finalized, 
the consolidated guidance will represent the current thinking of FDA on 
``Frequently Asked Questions--Statement of Investigator (Form FDA 1572) 
(Revision 1).'' 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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10612 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P


