Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
24633

Bulk drug substance
Uses evaluated
Melatonin

Treatment of sleep disorders in patients with autism spectrum disorder specifically children and adolescents.
Amyotrophic lateral sclerosis also known as ALS.
Pain management.
Peripheral neuropathy including diabetic neuropathy.
Inborn errors of metabolism also known as genetic metabolic disorders including methylenetetrahydrofolate reductase deficiency also known as MTHFR.
Hyperhomocysteinemia including conjunctive therapy in hemodialysis patients.
Vitamin B12 deficiency.
Autism spectrum disorder.
Treatment for patients with tetrahydrobiopterin BH4 deficiency.

Methylcobalamin

Oxitriptan 5HTP

The committee will also discuss revisions FDA is considering to the Withdrawn or Removed List. FDA now is considering whether to amend the rule to add one more entry to the list:
Neomycin Sulfate: All parenteral drug products containing neomycin sulfate except for ophthalmic or otic use, or when combined with polymyxin B
sulfate for irrigation of the intact bladder. As previously explained in the Federal Register of July 2, 2014 79 FR
37687 at 37689 through 37690, the list may specify that a drug may not be compounded in any form, or, alternatively, may expressly exclude a particular formulation, indication, dosage form, or route of administration from an entry on the list. Moreover, a drug may be listed only with regard to certain formulations, indications, routes of administration, or dosage forms because it has been found to be unsafe or not effective in those particular formulations, indications, routes of administration, or dosage forms. FDA
plans to seek the committees advice concerning the inclusion of this drug product on the list.
FDA intends to make background material available to the public no later than 2 business days before the meeting.
If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDAs website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the
VerDate Sep<11>2014

19:55 May 06, 2021

Jkt 253001

Docket see ADDRESSES on or before May 26, 2021, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:15 a.m., 12:25 p.m. to 12:40 p.m., 2:15 p.m. to 2:30 p.m., 3:35 p.m. to 3:50 p.m., and 4:40 p.m. to 4:55 p.m. Eastern Time.
Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 17, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 18, 2021.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Takyiah Stevenson see FOR FURTHER
INFORMATION CONTACT at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act 5
U.S.C. app. 2.

PO 00000

Frm 00052

Fmt 4703

Sfmt 4703

Dated: May 3, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202109621 Filed 5621; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2014N1414

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Class II Special Controls Guidance Document:
Labeling Natural Rubber Latex Condoms AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or we is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Submit written comments including recommendations on the collection of information by June 7, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting Currently under ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100633. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three SUMMARY:

E:FRFM07MYN1.SGM

07MYN1