Meeting of the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality), 8265-8266 [2022-03027]

Download as PDF jspears on DSK121TN23PROD with NOTICES1 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices contained the anabolic steroid Methyldienolone, a controlled substance prohibited under the Designer Steroid Act, 21 U.S.C. 802(41), which Mr. Parks also caused to be imported into the United States. Mr. Parks worked with others to conceal the importation of these and other unapproved drugs as they were disguised and misdeclared as articles of food, specifically ‘‘biscuit mix powder,’’ ‘‘corn powder,’’ ‘‘grain mix powder,’’ ‘‘bread mix powder,’’ and ‘‘milk tea powder.’’ Mr. Parks then included these drug active ingredients in MedFitRX products, which were unapproved drugs that he introduced and delivered for introduction into interstate commerce. Mr. Parks knowingly marketed these MedFitRX products as ‘‘dietary supplements’’ and ‘‘sports supplements’’ to create the impression they were safe and legal to use, and otherwise intentionally failed to include certain drug active ingredients on the product labels. As a result of this conviction, FDA sent Mr. Parks, by certified mail, on October 12, 2021, a notice proposing to debar him for a 5-year period from importing or offering for import any article of food or drug into the United States. The proposal was based on a finding under section 306(b)(1)(C) and (b)(3)(C) of the FD&C Act that Mr. Parks’ felony conviction of distribution of an unapproved new drug with the intent to defraud and mislead constitutes conduct relating to the importation into the United States of an article of food and any drug or controlled substance because Mr. Parks illegally imported unapproved drugs into the United States, working with others to disguise and misdeclare them as articles of food, and then distributed those unapproved drugs to consumers in the United States, marketing them as ‘‘dietary supplements’’ and ‘‘sports supplements.’’ In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Parks’ offense, and concluded that the felony offense warranted the imposition of a 5year period of debarment. The proposal informed Mr. Parks of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Parks received the proposal and notice of opportunity for a hearing on October 18, 2021. Mr. Parks failed to request a hearing within the timeframe prescribed VerDate Sep<11>2014 17:54 Feb 11, 2022 Jkt 256001 by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12). II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(1)(C) and (b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Brian Michael Parks has been convicted of a felony under Federal law for conduct relating to the importation into the United States of an article of food and of a drug or controlled substance, and that he is subject to a 5-year period of debarment. As a result of the foregoing finding, Mr. Parks is debarred for a period of 5 years from importing or offering for import articles of food or any drug or controlled substances into the United States, applicable (see DATES). Pursuant to section 301(cc) of the FD&C Act, the importing or offering for import into the United States of an article of food or of any drug or controlled substance by, with the assistance of, or at the direction of Mr. Parks is a prohibited act. Any application by Mr. Parks for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2021– N–0304 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20. Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. Dated: February 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–03098 Filed 2–11–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality) Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 8265 In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/ advisory-committees/infant-mortality/ index.html. SUMMARY: March 15, 2022, 12:00 p.m. to 4:00 p.m. Eastern Time and March 16, 2022, 12:00 p.m. to 4:00 p.m. Eastern Time. DATES: This meeting will be held virtually via webinar. The webinar link and log-in information will be available at the ACIMM website before the meeting: https://www.hrsa.gov/advisorycommittees/infant-mortality/. FOR FURTHER INFORMATION CONTACT: Anne Leitch, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443– 1321; or SACIM@hrsa.gov. SUPPLEMENTARY INFORMATION: ACIMM is authorized by section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended. The Committee is governed by provisions of Public Law 92–463, as amended, (5 U.S.C. App. 2), which sets forth standards for the formation and use of Advisory Committees. The ACIMM advises the Secretary of Health and Human Services (Secretary) on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy. The Committee provides advice on how to coordinate federal, state, local, tribal, and territorial governmental efforts designed to improve infant mortality, related adverse birth outcomes, and maternal health, as well as influence similar efforts in the private and voluntary sectors. The Committee provides guidance and recommendations on the policies, programs, and resources required to address the disparities and inequities in infant mortality, related adverse birth outcomes and maternal health outcomes, including maternal mortality and severe maternal morbidity. With its focus on underlying causes of the disparities and inequities seen in birth outcomes for women and infants, the Committee advises the Secretary on the health, social, economic, and environmental factors contributing to the inequities and proposes structural, policy, and/or systems level changes. ADDRESSES: E:\FR\FM\14FEN1.SGM 14FEN1 8266 Federal Register / Vol. 87, No. 30 / Monday, February 14, 2022 / Notices The agenda for the March 15–16, 2022, meeting is being finalized and may include the following topics: Federal program updates; COVID–19 updates; race-concordant care, health of indigenous mothers and babies; and, the impact of violence on infant and maternal mortality. Agenda items are subject to change as priorities dictate. Refer to the ACIMM website listed above for any updated information concerning the meeting. Members of the public will have the opportunity to provide written or oral comments. Requests to submit a written statement or make oral comments to ACIMM should be sent to Anne Leitch using the email address above at least 3 business days prior to the meeting. Public participants may submit written statements in advance of the scheduled meeting by emailing SACIM@hrsa.gov. Oral comments will be honored in the order they are requested and may be limited as time allows. Individuals who plan to attend and need special assistance or some reasonable accommodation should notify Anne Leitch at the contact information listed above at least 10 business days prior to the meeting. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2022–03027 Filed 2–11–22; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Health Security Strategy Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). ACTION: Request for information. AGENCY: The Office of the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), is soliciting public comment regarding national health security threats, challenges, and promising practices to help inform the development of the 2023–2026 National Health Security Strategy (NHSS). Since 2006, Congress has required the Secretary of HHS to develop and submit a 4-year NHSS and implementation plan that describe ‘‘potential emergency health security threats and identify the process to be prepared to identify and respond to such threats.’’ The quadrennial NHSS is a key U.S. Government vehicle for advancing public health and medical emergency capabilities, and serves as a tool to jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:54 Feb 11, 2022 Jkt 256001 address priority threats, measure progress, identify gaps, and focus action to implement national health security capabilities. DEPARTMENT OF HEALTH AND HUMAN SERVICES DATES: Comments must be received by March 11, 2022. Center for Scientific Review Amended; Notice of Meeting Comments must be submitted electronically via email to the following email address: NHSS@ hhs.gov. Instructions: Emails to NHSS@hhs.gov in response to this announcement should include ‘2023–2026 NHSS comments’ in the subject line. Responses to the Request for Information may be placed in the body of the email or in an attachment to the email using a standard document format. Request for Information: HHS/ASPR is preparing to draft the 2023–2026 NHSS. To help inform this strategy, HHS/ASPR is soliciting public comment regarding health security threats, challenges, and promising practices that may warrant being addressed in the 2023–2026 NHSS. We invite your response to the following questions. Please note that you are not limited to the questions below and we welcome additional feedback. • What are the most critical national health security threats and public health and medical preparedness, response, and recovery challenges that warrant increased attention over the next five years? • What medium-term and long-term (i.e., over next five years) actions should be taken to mitigate these challenges at the federal government and/or state, local, tribal, and territorial level? • What public health and medical preparedness, response, and recovery opportunities or promising practices should be capitalized on over the next five years? Disclaimer and Important Notes: This notice is intended for planning purposes and does not constitute a formal agreement that information from public responses will be included in the 2023– 2026 NHSS. Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel; Small Business: Biomedical Sensing, Measurement and Instrumentation Study Section, March 10–11, 2022, 9:30 a.m. to 7:00 p.m., which was published in the Federal Register on February 08, 2022, 87 FR 7194, FR DOC #2022– 02598. This meeting is being amended to change the Contact Person from Yuanna Cheng to James J. Li, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD. The meeting dates, times, and meeting location remain the same. The meeting is closed to the public. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Darrin Donato, Chief, Domestic Policy Branch, Division of Policy, Office of Strategy, Policy, Planning, and Requirements, ASPR, HHS, Washington, DC, NHSS@hhs.gov. Dawn O’Connell, Assistant Secretary for Preparedness and Response. [FR Doc. 2022–03046 Filed 2–11–22; 8:45 am] BILLING CODE 4150–37–P PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 National Institutes of Health Dated: February 8, 2022. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–03054 Filed 2–11–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Cancer Institute Council of Research Advocates. The meeting will be held as a virtual meeting and is open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https://videocast.nih.gov). Name of Committee: National Cancer Institute Council of Research Advocates. Date: March 9, 2022. Time: 12:00 p.m. to 4:15 p.m. Agenda: Welcome and Chairman’s Remarks, NCI Updates, Legislative Update, and Director’s Update. Place: National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892 (Virtual Meeting). E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8265-8266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Meeting of the Advisory Committee on Infant and Maternal 
Mortality (Formerly the Advisory Committee on Infant Mortality)

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Advisory Committee on Infant and Maternal 
Mortality (ACIMM or Committee) has scheduled a public meeting. 
Information about ACIMM and the agenda for this meeting can be found on 
the ACIMM website at https://www.hrsa.gov/advisory-committees/infant-mortality/.

DATES: March 15, 2022, 12:00 p.m. to 4:00 p.m. Eastern Time and March 
16, 2022, 12:00 p.m. to 4:00 p.m. Eastern Time.

ADDRESSES: This meeting will be held virtually via webinar. The webinar 
link and log-in information will be available at the ACIMM website 
before the meeting: https://www.hrsa.gov/advisory-committees/infant-mortality/.

FOR FURTHER INFORMATION CONTACT: Anne Leitch, Maternal and Child Health 
Bureau, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301-443-
1321; or [email protected].

SUPPLEMENTARY INFORMATION: ACIMM is authorized by section 222 of the 
Public Health Service Act (42 U.S.C. 217a), as amended. The Committee 
is governed by provisions of Public Law 92-463, as amended, (5 U.S.C. 
App. 2), which sets forth standards for the formation and use of 
Advisory Committees.
    The ACIMM advises the Secretary of Health and Human Services 
(Secretary) on department activities, partnerships, policies, and 
programs directed at reducing infant mortality, maternal mortality and 
severe maternal morbidity, and improving the health status of infants 
and women before, during, and after pregnancy. The Committee provides 
advice on how to coordinate federal, state, local, tribal, and 
territorial governmental efforts designed to improve infant mortality, 
related adverse birth outcomes, and maternal health, as well as 
influence similar efforts in the private and voluntary sectors. The 
Committee provides guidance and recommendations on the policies, 
programs, and resources required to address the disparities and 
inequities in infant mortality, related adverse birth outcomes and 
maternal health outcomes, including maternal mortality and severe 
maternal morbidity. With its focus on underlying causes of the 
disparities and inequities seen in birth outcomes for women and 
infants, the Committee advises the Secretary on the health, social, 
economic, and environmental factors contributing to the inequities and 
proposes structural, policy, and/or systems level changes.

[[Page 8266]]

    The agenda for the March 15-16, 2022, meeting is being finalized 
and may include the following topics: Federal program updates; COVID-19 
updates; race-concordant care, health of indigenous mothers and babies; 
and, the impact of violence on infant and maternal mortality. Agenda 
items are subject to change as priorities dictate. Refer to the ACIMM 
website listed above for any updated information concerning the 
meeting.
    Members of the public will have the opportunity to provide written 
or oral comments. Requests to submit a written statement or make oral 
comments to ACIMM should be sent to Anne Leitch using the email address 
above at least 3 business days prior to the meeting. Public 
participants may submit written statements in advance of the scheduled 
meeting by emailing [email protected]. Oral comments will be honored in 
the order they are requested and may be limited as time allows.
    Individuals who plan to attend and need special assistance or some 
reasonable accommodation should notify Anne Leitch at the contact 
information listed above at least 10 business days prior to the 
meeting.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-03027 Filed 2-11-22; 8:45 am]
BILLING CODE 4165-15-P

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