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Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices FOR FURTHER INFORMATION CONTACT:

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Colleen Locicero, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20903, 301
7961114.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. This draft guidance is intended to help sponsors developing individualized ASO drug products for a severely debilitating or life-threatening genetic disease.
The draft guidance addresses the approach for obtaining feedback from FDA, the expectations and process for making regulatory submissions to FDA, and high-level recommendations related to the requirement for institutional review board review of protocols for trials of individualized ASO drug products and the informed consent of participants. The draft guidance discusses the importance of early interaction with FDA, submission expectations for pre-investigational new drug IND meeting packages and IND
applications, and ethical and human subject protection considerations.
The draft guidance is intended to help sponsors of such development programs, who may be relatively unfamiliar with FDA regulations, processes, and practices, seek feedback from FDA on their development programs and make regulatory submissions related to these development programs. The draft guidance is expected to facilitate the preparation of adequate pre-IND and IND submissions for review by the Agency, which may help enable prompt initiation of the investigation.
This draft guidance represents the first of several guidances FDA intends to publish to advise and help sponsors developing individualized ASO drug products for patients who have severely debilitating or life-threatening diseases or conditions and no adequate alternative therapy available to them to treat their disease or condition.
This draft guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The draft guidance, when finalized, will represent the current thinking of FDA
on IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations. It does
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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 44 U.S.C. 35013521 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 for the submission of IND applications, amendments, and safety reports; for investigator brochures; and for requesting a pre-IND meeting have been approved under OMB control number 09100014; the collections of information for paper submissions of Form FDA 3500A have been approved under OMB control number 09100291;
the collections of information for electronic submissions of Form FDA
3500 have been approved under OMB
control number 09100645; the collections of information in 21 CFR
parts 50 and 56 for obtaining informed consent for prospective patients have been approved under OMB control number 09100755.
III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https
www.regulations.gov.
Dated: December 23, 2020.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202029119 Filed 1421; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimers Research, Care, and Services; Meeting Assistant Secretary for Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:

This notice announces the public meeting of the Advisory Council on Alzheimers Research, Care, and Services Advisory Council. The Advisory Council provides advice on how to prevent or reduce the burden of
SUMMARY:

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Alzheimers disease and related dementias on people with the disease and their caregivers. During the January 25, 2021 meeting the Advisory Council will hear presentations on the impact of COVID19 on people with dementia, health disparities in dementia research, and the implications of new technologies to identify Alzheimers disease through a blood tests.
DATES: The meeting will be held on January 25, 2021 from 1:00 p.m. to 4:30
p.m. EST.
ADDRESSES: The meeting will be virtual, streaming at http www.hhs.gov/live.
Comments: Time is allocated on the agenda to hear public comments from 4:00 p.m. to 4:30 p.m. The time for oral comments will be limited to two 2
minutes per individual. In order to provide a public comment, please register by emailing your name to napa@hhs.gov by Thursday, January 21.
Registered commenters will receive both a dial-in number and a link to join the meeting virtually; individuals will have the choice to either join virtually via the link, or to call in only by using the dialin number. Note: There may be a 3045
second delay in the livestream video presentation of the conference. For this reason, if you have pre-registered to submit a public comment, it is important to connect to the meeting by 3:45 p.m. to ensure that you do not miss your name and allotted time when called. If you miss your name and allotted time to speak, you may not be able to make your public comment. All participant audio lines will be muted for the duration of the meeting and only unmuted by the Host at the time of the participants public comment. Should you have questions during the session email napa@hhs.gov and someone will respond to your message as quickly as possible.
In order to ensure accuracy, please submit a written copy of oral comments for the record by emailing napa@
hhs.gov by Tuesday, January 26. These comments will be shared on the website and reflected in the meeting minutes.
In lieu of oral comments, formal written comments may be submitted for the record by Tuesday, January 26 to Helen Lamont, Ph.D., OASPE, 200
Independence Avenue SW, Room 424E, Washington, DC 20201. Comments may also be sent to napa@hhs.gov. Those submitting written comments should identify themselves and any relevant organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 2022606075, helen.lamont@hhs.gov. Note: The meeting will be available to the public live at www.hhs.gov/live.

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