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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
respond rapidly to this devastating pandemic. This supplemental award will allow NORC to enhance the capacity of LTC Ombudsman programs to address abuse, neglect and exploitation as programs begin to reenter long-term care facilities. This supplemental is consistent with the Coronavirus Response and Relief Supplemental Appropriations Act of 2021: Grants to Enhance Capacity of Long-Term Care Ombudsman Programs to Respond to Complaints of Abuse and Neglect of Residents in Long-Term Care Facilities during the COVID19 Public Health Emergency.
Program Name: National Ombudsman Resource Center.
Recipient: The National Consumer Voice for Quality Long-Term Care.
Period of Performance: The supplement award will be issued for the time period of April 1, 2021-September 30, 2022.
Total Award Amount: $25,000, FY
2021.
Award Type: Cooperative Agreement Supplement.
Statutory Authority: This program is authorized under Section 202 of the Older Americans Act.
Basis for Award: The objective of the National Ombudsman Resource Center is to support credible and effective Long-Term Care Ombudsman programs through the provision of technical assistance and training to state Ombudsman programs and to state agencies on aging. Each year the NORC
helps thousands of state and local Ombudsmen through its website, training and webinars and specialized technical assistance. It is the only resource center specialized to provide technical assistance to state Ombudsman programs. In addition, early in the pandemic NORC pivoted to provide relevant tools and training to help Ombudsman programs respond to the pandemic including the toolkit COVID19 Recover and Re-entry and Trauma-Informed webinars and dialogue to assist Ombudsman programs.
For More Information Contact: For further information or comments regarding this program supplement, contact Louise Ryan, U.S. Department of Health and Human Services, Administration for Community Living, Administration on Aging 206 615
2299; email Louise.Ryan@acl.hhs.gov.
Date: April 30, 2021.
Alison Barkoff, Acting Administrator and Assistant Secretary for Aging.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2014N0913

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; 513g Request for Information 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.
SUMMARY:

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 09100705. Also include the FDA docket number found in brackets in the heading of this document.

ADDRESSES:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

513g Request for Information OMB Control Number 09100705
Extension This information collection supports Agency regulations and accompanying guidance. Section 513g of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 360cg provides a means for obtaining the Agencys views about the classification and regulatory requirements that may be applicable to a particular device. Section 513g provides that, within 60 days of the
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receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act, the Secretary of Health and Human Services shall provide such person a written statement of the classification if any of such device and the requirements of the FD&C Act applicable to the device.
Regulations governing medical device classification procedures are codified under 21 CFR part 860.
The guidance document entitled FDA and Industry Procedures for Section 513g Requests for Information Under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff 1 establishes procedures for submitting, reviewing, and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513g of the FD&C Act. FDA does not review data related to substantial equivalence or safety and effectiveness in a 513g request for information.
FDAs responses to 513g requests for information are not device classification decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or approval for marketing require submissions under different sections of the FD&C Act.
Relatedly, the FD&C Act, as amended by the Food and Drug Administration Amendments Act of 2007 Pub. L. 110
85, requires FDA to collect user fees for 513g requests for information. The guidance document entitled User Fees for 513g Requests for Information;
Guidance for Industry and Food and Drug Administration Staff 2 assists FDA staff and regulated industry by describing the user fees associated with 513g requests. The Medical Device User Fee Cover Sheet Form FDA 3601, which accompanies the supplemental material described in this information collection is approved under OMB
control number 09100511.
In the Federal Register of January 13, 2021 86 FR 2674, FDA published a 60day notice requesting public comment on the proposed collection of information. We received five comments; however, the comments 1 https www.fda.gov/regulatory-information/
search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-informationunder-federal-food-drug-and-cosmetic.
2 https www.fda.gov/regulatory-information/
search-fda-guidance-documents/user-fees-513grequests-information.

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