Advisory Committee on Immunization Practices (ACIP), 71642-71643 [2021-27506]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 71642 Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices • FAR 52.216–2, Economic Price Adjustment-Standard Supplies; FAR 52.216–3, Economic Price AdjustmentSemistandard Supplies; and FAR 52.216–4, Economic Price AdjustmentLabor and Material. These clauses require contractors on contracts that provide for economic price adjustments to promptly notify the contracting officer of any increases or decreases to established prices or labor rates (including fringe) because of certain contingencies, such as increases or decreases to established catalog or market prices or changes to cost indexes for labor or materials. The contracting officer uses the information provided by the contractor to negotiate price adjustments under the contract due to the contingency specified in the contract. • FAR 52.216–5, Price Redetermination-Prospective. Paragraph (c) of this clause requires a contractor on a fixed-price contract with prospective price redetermination to submit to the Government (within an agreed upon timeframe) a statement of costs incurred for the most recent period of performance, the proposed prices for the upcoming contract period, and any supporting or relevant documentation. Per paragraph (h) of this clause, during periods where firm prices have not been established, the contractor must also submit quarterly statements that includes a breakdown of total contract prices, costs, and profit incurred and all invoices accepted for delivered items or services for which final prices have not been established. The contracting officer uses the information to negotiate/ redetermine fair and reasonable prices for supplies and services that may be delivered or performed under the contract in the period following the effective date of price redetermination. • FAR 52.216–6, Price Redetermination-Retroactive. Paragraph (c) of this clause requires a contractor on a fixed-ceiling-price contract with retroactive price redetermination to submit to the Government (within an agreed upon timeframe after completion of the contract) the proposed prices, all costs incurred in performing the contract, and any supporting or relevant documentation. Per paragraph (g) of this clause, until final price redetermination has been completed, the contractor must also submit a quarterly statement that includes a breakdown of total contract prices, costs, and interim profit incurred and all invoices accepted for delivered items. The contracting officer uses the information provided by the contractor to negotiate/redetermine fair and reasonable prices for supplies and services that have already been VerDate Sep<11>2014 17:39 Dec 16, 2021 Jkt 256001 delivered or performed under the contract. • FAR 52.216–16, Incentive Price Revision–Firm Target; and FAR 52.216– 17, Incentive Price Revision–Successive Targets. These clauses require contractors on fixed price incentive (firm or successive target) contracts to submit to the Government on a quarterly basis a statement regarding total contract prices, costs, portions of interim profit, and amounts of invoices or vouchers for completed work that is cumulative from the beginning of the contract (see 52.216–16(g) and 52.216– 17(i)). Upon final delivery of supplies or completion of services for covered line items, the contractor is required to submit a detailed statement of all costs incurred up to the end of that month in performing all work under the items; an estimate of costs of further performance, if any, that may be necessary to complete performance of all work under the items; a list of all residual inventory and an estimate of its value; and any other relevant data that the Contracting Officer may reasonably require (see 52.216–16(c) and 52.216–17(e)). Paragraph (c) of 52.216–17 also requires submission of data for establishing the firm fixed price or a final profit adjustment formula. The contracting officer uses the information provided by the contractor to evaluate the contractor’s performance in meeting the incentive target and to negotiate the final prices of incentive-related items and services. C. Annual Burden Respondents: 9,162. Total Annual Responses: 61,580. Total Burden Hours: 114,743. Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division, by calling 202–501–4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000–0067, Certain Federal Acquisition Regulation Part 16 Contract Pricing Requirements. Janet Fry, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2021–27246 Filed 12–16–21; 8:45 am] BILLING CODE 6820–EP–P PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2021–0133] Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting and request for comment. AGENCY: In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web. DATES: The meeting will be held on December 16, 2021, from 12 p.m. to 4 p.m., EST (times subject to change). Written comments are due December 23, 2021. ADDRESSES: You may submit comments identified by Docket No. CDC–2021– 0133 by any of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H24–8, Atlanta, Georgia 30329– 4027, Attn: ACIP Meeting. Instructions: All submissions received must include the Agency name and Docket Number. All relevant comments received in conformance with the https://www.regulations.gov suitability policy will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. Written public comments will be provided to ACIP members. FOR FURTHER INFORMATION CONTACT: Stephanie Thomas, ACIP Committee Management Specialist, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, 1600 Clifton Road NE, MS H24–8, Atlanta, Georgia 30329– 4027; Telephone: (404) 639–8367; Email: ACIP@cdc.gov. SUPPLEMENTARY INFORMATION: In accordance with 41 CFR 102–3.150(b), less than 15 calendar days’ notice is being given for this meeting due to the exceptional circumstances of the SUMMARY: E:\FR\FM\17DEN1.SGM 17DEN1 Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices jspears on DSK121TN23PROD with NOTICES1 COVID–19 pandemic and rapidly evolving COVID–19 vaccine development and regulatory processes. The Secretary of Health and Human Services has determined that COVID–19 is a Public Health Emergency. A notice of this ACIP meeting has also been posted on CDC’s ACIP website at: https:// www.cdc.gov/vaccines/acip/. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about the ACIP. Purpose: The committee is charged with advising the Director, CDC, on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under provisions of the Affordable Care Act, section 2713 of the Public Health Service Act, immunization recommendations of the ACIP that have been approved by the CDC Director and appear on CDC immunization schedules must be covered by applicable health plans. Matters To Be Considered: The agenda will include discussions on Janssen (Johnson & Johnson) COVID–19 vaccine safety. A recommendation vote is scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit https://www.cdc.gov/vaccines/acip/ meetings/meetings-info.html. Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/ near duplicate examples of a mass-mail VerDate Sep<11>2014 17:39 Dec 16, 2021 Jkt 256001 campaign. CDC will carefully consider all comments submitted into the docket. Written Public Comment: Written comments must be received on or before December 23, 2021. Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP’s Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below. Procedure for Oral Public Comment: All persons interested in making an oral public comment at the December 16, 2021 ACIP meeting must submit a request at https://www.cdc.gov/vaccines/ acip/meetings/ no later than 8 a.m., EST, December 16, 2021, according to the instructions provided. If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by December 16, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–27506 Filed 12–15–21; 4:15 pm] BILLING CODE 4163–18–P PO 00000 71643 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3926] Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before February 15, 2022, will be given first consideration for membership on the Panels of the MDAC. Nominations received after February 15, 2022, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal at https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. SUMMARY: FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, contact the following persons listed in table 1: Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71642-71643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27506]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2021-0133]


Advisory Committee on Immunization Practices (ACIP)

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of meeting and request for comment.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Federal Advisory Committee Act, the 
Centers for Disease Control and Prevention (CDC) announces the 
following meeting of the Advisory Committee on Immunization Practices 
(ACIP). This meeting is open to the public. Time will be available for 
public comment. The meeting will be webcast live via the World Wide 
Web.

DATES: The meeting will be held on December 16, 2021, from 12 p.m. to 4 
p.m., EST (times subject to change). Written comments are due December 
23, 2021.

ADDRESSES: You may submit comments identified by Docket No. CDC-2021-
0133 by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Centers for Disease Control and Prevention, 1600 
Clifton Road NE, MS H24-8, Atlanta, Georgia 30329-4027, Attn: ACIP 
Meeting.
    Instructions: All submissions received must include the Agency name 
and Docket Number. All relevant comments received in conformance with 
the https://www.regulations.gov suitability policy will be posted 
without change to https://www.regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to https://www.regulations.gov.
    Written public comments will be provided to ACIP members.

FOR FURTHER INFORMATION CONTACT: Stephanie Thomas, ACIP Committee 
Management Specialist, Centers for Disease Control and Prevention, 
National Center for Immunization and Respiratory Diseases, 1600 Clifton 
Road NE, MS H24-8, Atlanta, Georgia 30329-4027; Telephone: (404) 639-
8367; Email: [email protected].

SUPPLEMENTARY INFORMATION: In accordance with 41 CFR 102-3.150(b), less 
than 15 calendar days' notice is being given for this meeting due to 
the exceptional circumstances of the

[[Page 71643]]

COVID-19 pandemic and rapidly evolving COVID-19 vaccine development and 
regulatory processes. The Secretary of Health and Human Services has 
determined that COVID-19 is a Public Health Emergency. A notice of this 
ACIP meeting has also been posted on CDC's ACIP website at: https://www.cdc.gov/vaccines/acip/. In addition, CDC has sent notice 
of this ACIP meeting by email to those who subscribe to receive email 
updates about the ACIP.
    Purpose: The committee is charged with advising the Director, CDC, 
on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, 
the committee is mandated to establish and periodically review and, as 
appropriate, revise the list of vaccines for administration to vaccine-
eligible children through the Vaccines for Children program, along with 
schedules regarding dosing interval, dosage, and contraindications to 
administration of vaccines. Further, under provisions of the Affordable 
Care Act, section 2713 of the Public Health Service Act, immunization 
recommendations of the ACIP that have been approved by the CDC Director 
and appear on CDC immunization schedules must be covered by applicable 
health plans.
    Matters To Be Considered: The agenda will include discussions on 
Janssen (Johnson & Johnson) COVID-19 vaccine safety. A recommendation 
vote is scheduled. Agenda items are subject to change as priorities 
dictate. For more information on the meeting agenda visit https://www.cdc.gov/vaccines/acip/meetings/meetings-info.html.

Public Participation

    Interested persons or organizations are invited to participate by 
submitting written views, recommendations, and data. Please note that 
comments received, including attachments and other supporting 
materials, are part of the public record and are subject to public 
disclosure. Comments will be posted on https://www.regulations.gov. 
Therefore, do not include any information in your comment or supporting 
materials that you consider confidential or inappropriate for public 
disclosure. If you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be on public display. CDC will review all submissions 
and may choose to redact, or withhold, submissions containing private 
or proprietary information such as Social Security numbers, medical 
information, inappropriate language, or duplicate/near duplicate 
examples of a mass-mail campaign. CDC will carefully consider all 
comments submitted into the docket.
    Written Public Comment: Written comments must be received on or 
before December 23, 2021.
    Oral Public Comment: This meeting will include time for members of 
the public to make an oral comment. Oral public comment will occur 
before any scheduled votes including all votes relevant to the ACIP's 
Affordable Care Act and Vaccines for Children Program roles. Priority 
will be given to individuals who submit a request to make an oral 
public comment before the meeting according to the procedures below.
    Procedure for Oral Public Comment: All persons interested in making 
an oral public comment at the December 16, 2021 ACIP meeting must 
submit a request at https://www.cdc.gov/vaccines/acip/meetings/ no later 
than 8 a.m., EST, December 16, 2021, according to the instructions 
provided.
    If the number of persons requesting to speak is greater than can be 
reasonably accommodated during the scheduled time, CDC will conduct a 
lottery to determine the speakers for the scheduled public comment 
session. CDC staff will notify individuals regarding their request to 
speak by email by December 16, 2021. To accommodate the significant 
interest in participation in the oral public comment session of ACIP 
meetings, each speaker will be limited to 3 minutes, and each speaker 
may only speak once per meeting.
    The Director, Strategic Business Initiatives Unit, Office of the 
Chief Operating Officer, Centers for Disease Control and Prevention, 
has been delegated the authority to sign Federal Register notices 
pertaining to announcements of meetings and other committee management 
activities, for both the Centers for Disease Control and Prevention and 
the Agency for Toxic Substances and Disease Registry.

Kalwant Smagh,
Director, Strategic Business Initiatives Unit, Office of the Chief 
Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2021-27506 Filed 12-15-21; 4:15 pm]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.