What’s
in today’s Policy Round Up?
- Updated CDC guidance on COVID-19
vaccine boosters and additional doses
- Call for comments on:
- HHS Strategic Plan
- FDA’s landmark proposal to improve
access to hearing aid technology and proposed
guidance on hearing aids and personal amplification
devices
- Proposed rule that would prohibit
payment of subminimum wages by nonprofits in the
AbilityOne Program.
- New Department of Education
resource for supporting student mental health
Updated
CDC guidance on COVID-19 vaccine boosters; additional doses
CDC has now issued
booster recommendations for all three COVID-19 vaccines.
Booster eligibility criteria are based on which vaccine you
received initially.
- If you received the Johnson & Johnson
vaccine, you are eligible for a booster if you are at
least 18 years old and you received your shot at least
two months ago - regardless of age, disability, or
other risk factors.
- If you received the Pfizer or
Moderna vaccines, you are eligible for a booster if
you received your second dose at least six months ago,
and you are:
If you are eligible for a booster, you may
choose any of
the three available vaccines, regardless of which you
received initially.
Finally, CDC also recommends additional
doses of the COVID-19 vaccine if:
- you are moderately
or severely immunocompromised, and;
- you received your second Pfizer or
Moderna shot at least 28 days ago. (The additional
dose guidance does not currently apply to people who
received the Johnson & Johnson vaccine.)
Note: "Mix-and-match"
is NOT recommended for additional dosages; people
receiving an additional dose due to a compromised immune
system should receive an additional dose of the same
vaccine they received initially.
Input
Needed: Proposed rule would prohibit payment of subminimum
wages by nonprofits in the AbilityOne Program.
A proposed rule would require nonprofit
agencies seeking to qualify (or maintain qualifications)
under the AbilityOne program to certify that it will not
pay subminimum wages using special wage certificates
authorized under section 14(c) of the Fair Labor Standards
Act of 1938. This would apply to employees on all contracts
or subcontracts awarded, extended (other than through the
exercise of an option) or renewed after the effective date
of the final rule. Comments
must be received by November 12.
Instructions for submitting comments can be found in the Federal
Register notice.
Input
needed: HHS Strategic Plan
The Department of Health and Human Services
is seeking
public comment on its draft strategic plan, which
outlines the Department’s goals for the next four years.
The plan covers many issues of particular importance to
people with disabilities and older adults, such as
improving access to and quality of home and community-based
services, reducing healthcare costs, and bolstering the
healthcare workforce, so the input of the aging and
disability networks is critical. Comments are due by
Nov. 7.
Read more.
Input Needed: FDA Guidance
on Hearing Aids and Personal Sound Amplification Products
FDA is seeking input on a proposed rule and
a draft updated guidance. Comments for both are due by Jan. 18,
2022
- Proposed rule: Medical
Devices; Ear, Nose, and Throat Devices; Establishing
Over-the-Counter Hearing Aids. The rule
creates a new category of OTC devices that would apply
to some air-conduction hearing aids intended for
adults age 18 and older who have perceived mild to
moderate hearing loss. (Hearing aids for severe
hearing loss or for users younger than age 18 would be
prescription devices.) This would allow for hearing
aids to be sold directly to consumers in stores or
online without a medical exam or a fitting by an
audiologist. The rule includes additional details
related to pitch, volume, and labeling requirements. See
the Federal
Register notice for instructions for submitting
comments.
- Draft guidance: Regulatory
Requirements for Hearing Aid Devices and Personal
Sound Amplification Products (PSAPs). This
guidance describes hearing aids and PSAPS, their uses
and regulatory requirements that apply to both types
of products. The draft guidance is intended to provide
further clarification regarding the differences
between PSAPs, which help people with normal hearing
amplify sounds, and hearing aids and to inform
consumers that PSAPs are not considered OTC
alternatives for hearing aids. FDA’s
website has the guidance and instructions for
comments.
New Department of
Education Resource for Supporting Student Mental Health
On October 19, the U.S. Department of
Education released
a new resource, Supporting
Child and Student Social, Emotional, Behavioral and Mental
Health, which highlights seven key
challenges to providing school- or program-based mental
health support education settings and provides
corresponding recommendations for addressing them. This
document is part of the Return to School
Roadmap , which stresses the importance of
supporting students' social, emotional and mental health to
create a strong foundation for students' academic success. State Education
Agencies and local school districts can use the resources
in the American Rescue Plan's Elementary and Secondary
School Emergency Relief program (ARP ESSER), as well as
previous rounds of ESSER funds, to implement these
recommendations and ensure students receive the support
they need.
Read more.
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