83 FR 63891 - Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living Federal Register Volume 83, Issue 238 (December 12, 2018)
Administration for Community Living
Federal Register Volume 83, Issue 238 (December 12, 2018)
| Page Range | 63891-63892 | |
| FR Document | 2018-26857 |
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)] [Notices] [Pages 63891-63892] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26857] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities AGENCY: Administration for Community Living, HHS. ACTION: Notice of rescheduled meeting due to the closure of federal offices on December 5, 2018. ----------------------------------------------------------------------- SUMMARY: The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format. DATES: Webinar/Conference Call: Wednesday, December 12, 2018 from 9:00 a.m. to 10:00 a.m. (EST). FOR FURTHER INFORMATION CONTACT: For further information and accommodations needs, please contact Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC [[Page 63892]] 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email: [email protected]. SUPPLEMENTARY INFORMATION: The purpose of this virtual meeting is to discuss the Committee's preparation of the 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. This meeting was originally scheduled for December 5 from 9:00-10:00 a.m. (EST). This meeting is rescheduled to December 12 from 9:00-10:00 a.m. (EST) due to the closure of Federal offices on December 5 and to allow for the call to occur before the end of year. Agenda: The Committee will discuss the preparation of the PCPID 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. Webinar/Conference Call: The webinar/conference call is scheduled for Wednesday, December 12, 2018, 9:00 a.m. to 10:00 a.m. (EST) and may end early if discussions are finished. Instructions to Participate in the Webinar/Conference Call on Wednesday, December 12, 2018: Please dial: (888) 949-2790; Pass Code: 1989852. Background Information on the Committee: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expanding employment opportunities; (B) connecting people to services; (C) supporting families and caregivers; (D) strengthening the networks; and (E) protecting rights and preventing abuse. Dated: December 6, 2018. Julie Hocker, Commissioner, Administration on Disabilities (AoD). [FR Doc. 2018-26857 Filed 12-11-18; 8:45 am] BILLING CODE 4154-01-P
![Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices 63891
application form and rank applications barriers and facilitators for those million heart attacks and strokes, and
by reported hypertension control rate. strategies. Based on the information controlling hypertension is one focus of
In the second phase of assessment, collected for Challenges in 2013 through the initiative. CDC will use the
applicants with the highest preliminary 2017, CDC recognized a total of 83 information collected through the
scores are asked to participate in a two- public and private health care practices Million Hearts® Hypertension Control
hour data verification and validation and systems as Million Hearts® Challenge to increase widespread
process. The applicant reviews the Hypertension Control Champions. The attention to hypertension at the clinical
application form with a reviewer, Champions are announced roughly practice level, improve understanding of
describes how information was obtained annually, approximately six months successful and sustainable
from the providers’, practices’, or after the Challenge application period implementation strategies at the practice
healthcare systems’ electronic records, ends. The current OMB approval for or health system level, bring visibility to
chart reviews, or other sources, and information collection expires organizations that invest in
reviews the methodology used to December 31, 2019.
calculate the reported hypertension CDC plans to continue the Million hypertension control, and motivate
control rate. Data verification and Hearts® Hypertension Control Challenge individual practices to strengthen their
validation is conducted to ensure that through 2022 with revisions. The 2020 hypertension control efforts.
all applicants meet eligibility criteria Challenge is planned to launch in Information collected through the
and assure accuracy of their reported February 2020, coinciding with Million Hearts® Hypertension Control
hypertension control rate according to a American Heart Month. The application Challenge will link success in clinical
standardized method. Applicants must period will be open for approximately outcomes of hypertension control with
have achieved a hypertension control 45–60 days, with recognition of the information about strategies that can be
rate of at least 80% among their adult 2020 Champions in the fall of 2020. A used to achieve similar favorable
patients aged 18–85 years with similar calendar year schedule is outcomes so that the strategies can be
hypertension. planned for 2021 and 2022. Revision for replicated by other providers and health
Finalists who pass the data 2020, 2021, and 2022 includes a care systems.
verification and validation process and reduction in the estimated number of
background check will be reviewed by respondents. During the period of this OMB approval for a revision is
a CDC panel of judges to determine the Renewal request, on an annual basis, requested for three years. CDC estimates
Champion status. Several Champions CDC estimates that information will be that up to 200 applicants will submit an
will be asked to participate in a one- collected from up to 200 applicants application covered by this information
hour, semi-structured interview and using the application form, at most 40 collection each year. It is estimated that
provide detailed information about the data verifications, and at most 35 semi- information collection activities will
patient population served, the structured interviews. There is an total 215 burden hours per year. This
geographic region served, and the overall reduction in estimated represents a decrease in the estimated
strategies employed by the practice or annualized burden hours. annualized burden hours from 370
health system to achieve exemplary The overall goal of the Million hours to 215 hours. There is no cost to
rates of hypertension control, including Hearts® initiative is to prevent one respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Physicians, Practices, and Million Hearts® Hypertension Con- 200 1 30/60 100
healthcare systems. trol Champion Application form.
Finalists ............................................. Data Verification Form ..................... 40 1 2 80
Champions ........................................ Semi-structured interview guide ....... 35 1 1 35
Total ........................................... ........................................................... ........................ ........................ ........................ 215
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND (PCPID) will host a webinar/conference
Acting Lead, Information Collection Review HUMAN SERVICES call for its members to discuss the
Office, Office of Scientific Integrity, Office potential topics of the Committee’s 2019
of Science, Centers for Disease Control and Administration for Community Living Report to the President. All the PCPID
Prevention. meetings, in any format, are open to the
[FR Doc. 2018–26876 Filed 12–11–18; 8:45 am] Administration on Intellectual and public. This virtual meeting will be
Developmental Disabilities, President’s conducted in a discussion format.
BILLING CODE 4163–18–P
Committee for People With Intellectual
Disabilities DATES: Webinar/Conference Call:
Wednesday, December 12, 2018 from
AGENCY: Administration for Community
amozie on DSK3GDR082PROD with NOTICES1
9:00 a.m. to 10:00 a.m. (EST).
Living, HHS.
ACTION: Notice of rescheduled meeting FOR FURTHER INFORMATION CONTACT: For
due to the closure of federal offices on further information and
December 5, 2018. accommodations needs, please contact
Ms. Allison Cruz, Director, Office of
SUMMARY: The President’s Committee Innovation, 330 C Street SW, Switzer
for People with Intellectual Disabilities Building, Room 1114, Washington, DC
VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/83_FR_64129/page/1.svg)
![63892 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
20201. Telephone: 202–795–7334. Fax: DEPARTMENT OF HEALTH AND do not wish to be made available to the
202–795–7334. Email: allison.cruz@ HUMAN SERVICES public, submit the comment as a
acl.hhs.gov. written/paper submission and in the
Food and Drug Administration manner detailed (see ‘‘Written/Paper
SUPPLEMENTARY INFORMATION: The Submissions’’ and ‘‘Instructions’’).
[Docket No. FDA–2018–D–4267]
purpose of this virtual meeting is to
discuss the Committee’s preparation of Written/Paper Submissions
Biomarker Qualification: Evidentiary
the 2019 Report to the President, Framework; Draft Guidance for Submit written/paper submissions as
including its content and format, and Industry and Food and Drug follows:
related data collection and analysis Administration Staff; Availability • Mail/Hand Delivery/Courier (for
required to complete the writing of the written/paper submissions): Dockets
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and
Report. This meeting was originally
HHS. Drug Administration, 5630 Fishers
scheduled for December 5 from 9:00–
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852.
10:00 a.m. (EST). This meeting is
rescheduled to December 12 from 9:00– SUMMARY: The Food and Drug • For written/paper comments
10:00 a.m. (EST) due to the closure of Administration (FDA or Agency) is submitted to the Dockets Management
Federal offices on December 5 and to announcing the availability of a draft Staff, FDA will post your comment, as
allow for the call to occur before the end guidance for industry and FDA staff well as any attachments, except for
of year. entitled ‘‘Biomarker Qualification: information submitted, marked and
Evidentiary Framework.’’ This draft identified, as confidential, if submitted
Agenda: The Committee will discuss as detailed in ‘‘Instructions.’’
the preparation of the PCPID 2019 guidance provides recommendations on
general considerations to address when Instructions: All submissions received
Report to the President, including its must include the Docket No. FDA–
developing a biomarker for qualification
content and format, and related data 2018–D–4267 for ‘‘Biomarker
under the 21st Century Cures Act (Cures
collection and analysis required to Qualification: Evidentiary Framework;
Act), enacted on December 13, 2016,
complete the writing of the Report. that added a new section to the Federal Draft Guidance for Industry and FDA
Webinar/Conference Call: The Food, Drug, and Cosmetic Act (FD&C Staff.’’ Received comments will be
webinar/conference call is scheduled for Act). Qualification of a biomarker is a placed in the docket and, except for
Wednesday, December 12, 2018, 9:00 determination that within the stated those submitted as ‘‘Confidential
a.m. to 10:00 a.m. (EST) and may end context of use, the biomarker can be Submissions,’’ publicly viewable at
early if discussions are finished. relied on to have a specific https://www.regulations.gov or at the
interpretation and application in drug Dockets Management Staff between 9
Instructions to Participate in the
development and regulatory review. a.m. and 4 p.m., Monday through
Webinar/Conference Call on Friday.
Wednesday, December 12, 2018: Please DATES: Submit either electronic or
written comments on the draft guidance • Confidential Submissions—To
dial: (888) 949–2790; Pass Code: submit a comment with confidential
1989852. by February 11, 2019 to ensure that the
Agency considers your comment on this information that you do not wish to be
Background Information on the draft guidance before it begins work on made publicly available, submit your
Committee: The PCPID acts in an the final version of the guidance. comments only as a written/paper
advisory capacity to the President and ADDRESSES: You may submit comments submission. You should submit two
the Secretary of Health and Human on any guidance at any time as follows: copies total. One copy will include the
Services on a broad range of topics information you claim to be confidential
relating to programs, services and Electronic Submissions with a heading or cover note that states
support for individuals with intellectual Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
disabilities. The PCPID executive order following way: CONFIDENTIAL INFORMATION.’’ The
stipulates that the Committee shall: (1) • Federal eRulemaking Portal: Agency will review this copy, including
Provide such advice concerning https://www.regulations.gov. Follow the the claimed confidential information, in
intellectual disabilities as the President instructions for submitting comments. its consideration of comments. The
or the Secretary of Health and Human Comments submitted electronically, second copy, which will have the
including attachments, to https:// claimed confidential information
Services may request; and (2) provide
www.regulations.gov will be posted to redacted/blacked out, will be available
advice to the President concerning the
the docket unchanged. Because your for public viewing and posted on
following for people with intellectual
comment will be made public, you are https://www.regulations.gov. Submit
disabilities: (A) Expanding employment both copies to the Dockets Management
solely responsible for ensuring that your
opportunities; (B) connecting people to Staff. If you do not wish your name and
comment does not include any
services; (C) supporting families and confidential information that you or a contact information to be made publicly
caregivers; (D) strengthening the third party may not wish to be posted, available, you can provide this
networks; and (E) protecting rights and such as medical information, your or information on the cover sheet and not
preventing abuse. anyone else’s Social Security number, or in the body of your comments and you
Dated: December 6, 2018. confidential business information, such must identify this information as
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
amozie on DSK3GDR082PROD with NOTICES1
Julie Hocker,
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Commissioner, Administration on Disabilities
(AoD). information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
[FR Doc. 2018–26857 Filed 12–11–18; 8:45 am]
comments, that information will be more information about FDA’s posting
BILLING CODE 4154–01–P of comments to public dockets, see 80
posted on https://www.regulations.gov.
• If you want to submit a comment FR 56469, September 18, 2015, or access
with confidential information that you the information at: https://www.gpo.gov/
VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/83_FR_64129/page/2.svg)
Document Created: 2018-12-12 01:39:28
Document Modified: 2018-12-12 01:39:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of rescheduled meeting due to the closure of federal offices on December 5, 2018. | |
| Dates | Webinar/Conference Call: Wednesday, December 12, 2018 from 9:00 a.m. to 10:00 a.m. (EST). | |
| Contact | For further information and accommodations needs, please contact Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email: [email protected] | |
| FR Citation | 83 FR 63891 |
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