Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx-NEW, 66569-66570 [2020-23114]

Download as PDF Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices customer who did not have a prescription for them. A member of the conspiracy caused the customs declaration on the parcel to falsely report that the parcel contained a health product sample with no declared value. As a result of this conviction, FDA sent Mr. Komar, by certified mail on June 11, 2020, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Komar’s felony conviction for one felony count under Federal law for mail fraud was for conduct relating to the importation into the United States of any drug or controlled substance because he illegally caused bicalutamide and isotretinoin to be introduced in interstate commerce from Mumbai, India, by selling to a consumer who did not have a prescription through the U.S. mail in violation of 18 U.S.C. 1341. 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. Komar’s offenses and concluded that this felony offense warranted the imposition of a 5-year period of debarment. The proposal informed Mr. Komar of the proposed debarment and offered Mr. Komar 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. Komar received the proposal and notice of opportunity for a hearing on June 22, 2020. Mr. Komar failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12). years from importing or offering for import any drug into the United States, effective (see DATES). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug or controlled substance by, with the assistance of, or at the direction of Mr. Komar is a prohibited act. Any application by Mr. Komar for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA–2020– N–1058 and sent to the Dockets Management Staff (see ADDRESSES). The public availability of information in these submissions is governed by 21 CFR 10.20(j). 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. II. Findings and Order Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Keith Komar has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Mr. Komar is debarred for a period of 5 SUMMARY: VerDate Sep<11>2014 18:08 Oct 19, 2020 Jkt 253001 Dated: October 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–23135 Filed 10–19–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906–xxxx–NEW Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA’s ICR only after the 30 day comment period for this notice has closed. Comments on this ICR should be received no later than November 19, 2020. DATES: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 66569 Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906–xxxx [NEW]. Abstract: HRSA programs provide health care to people who are geographically isolated, economically, or medically vulnerable. HRSA programs help those in need of high quality primary health care, such as pregnant women and mothers. Improving maternal health outcomes and access to quality maternity care services is a key component of the HRSA mission. HRSA’s Maternal and Child Health Bureau (MCHB) provides funding to address some of the most urgent issues influencing the high rates of maternal mortality. Recent efforts to address persistent disparities in maternal, infant, and child health have employed a ‘‘life course’’ perspective and health equity lens focused on health promotion and disease prevention. Life course approach can be defined as analyzing people’s lives within structural, social, and cultural contexts through a defined sequence of age categories that people are normally expected to pass through as they progress from birth to death. Health equity is defined as the attainment of the highest level of health for all people. Achieving health equity for pregnant and postpartum women will require attention to barriers in access to quality health services and promotion of equal opportunities to seek the highest possible level of health and well-being. Achieving health equity also requires a focus on social determinants of health. With this emphasis on improving maternal health across the life course and promoting optimal health for all mothers, HRSA is employing a multipronged strategy to address maternal mortality and severe maternal morbidity through the following suite of programs: 1. The State Maternal Health Innovation Program; ADDRESSES: E:\FR\FM\20OCN1.SGM 20OCN1 66570 Federal Register / Vol. 85, No. 203 / Tuesday, October 20, 2020 / Notices 2. The Alliance for Innovation on Maternal Health Program: 3. The Alliance for Innovation on Maternal Health—Community Care Initiative; 4. The Rural Maternity and Obstetrics Management Strategies Program; and, 5. The Supporting Maternal Health Innovation Program. MCHB is conducting a portfolio-wide evaluation of HRSA-supported Maternal Health (MH) Programs with a primary focus on reducing maternal mortality. Through this evaluation, MCHB seeks to identify individual and/or collective strategies, interrelated activities, and common themes within and across the MH Programs that may be contributing to or driving improvements in key maternal health outcomes. MCHB seeks to ascertain which components should be elevated and replicated to the national level, as well as inform future investments to reduce rates of maternal mortality and severe maternal morbidity. A 60-day notice was published in the Federal Register on June 8, 2020, vol. 85, No. 110; pp. 34739–40. There were no public comments. Need and Proposed Use of the Information: MCHB seeks to understand the impact of HRSA’s investments in MH programs. These five programs represent a total of 12 state-based programs and three programs with the potential for national reach. In understanding the strategies that are most effective in reducing maternal morbidity and mortality, program elements could be replicated and/or scaled up nationally. Likely Respondents: Likely respondents are recipients of the cooperative agreements mentioned above (The State Maternal Health Innovation Program; The Alliance for Innovation on Maternal Health Program; The Alliance for Innovation on Maternal Health—Community Care Initiative; The Rural Maternity and Obstetrics Management Strategies Program; and, The Supporting Maternal Health Innovation Program) which represents 11 state health agencies, two national organizations, and two academic organizations. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Instrument Instrument Instrument Instrument 1: 2: 3: 4: Number responses per respondent Total responses Average burden per response (in hours) Total burden hours Interview guide for grantee staff .................... Interview guide for HRSA POs ...................... Partnership Survey ........................................ Web-based data collection tool ..................... 75 7 290 15 1 1 1 1 75 7 290 15 1.00 1.50 0.25 0.50 75.0 10.5 72.5 7.5 Total .............................................................................. 387 ........................ 387 ........................ 165.5 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–23114 Filed 10–19–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 18:08 Oct 19, 2020 Jkt 253001 amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Societal and Ethical Issues in Research. Date: November 12, 2020. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Benjamin Greenberg Shapero, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Room 3182, Bethesda, MD 20892, (301) 402– 4786, shaperobg@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Stress, Sleep, Disparities, and Aging. Date: November 16, 2020. Time: 12:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Benjamin G. Shapero, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3182, Bethesda, MD 20892, (301) 402–4786, shaperobg@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowship: Cancer Immunology and Immunotherapy. Date: November 17–18, 2020. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sarita Kandula Sastry, Ph.D., Scientific Review Officer, Center for E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 85, Number 203 (Tuesday, October 20, 2020)]
[Notices]
[Pages 66569-66570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23114]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Information Collection 
Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 
0906-xxxx-NEW

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

ACTION: Notice.

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

SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, 
HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period. OMB may act on HRSA's ICR only after the 30 
day comment period for this notice has closed.

DATES: Comments on this ICR should be received no later than November 
19, 2020.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under Review--Open for 
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: Information Collection Request Title: 
Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx [NEW].
    Abstract: HRSA programs provide health care to people who are 
geographically isolated, economically, or medically vulnerable. HRSA 
programs help those in need of high quality primary health care, such 
as pregnant women and mothers. Improving maternal health outcomes and 
access to quality maternity care services is a key component of the 
HRSA mission. HRSA's Maternal and Child Health Bureau (MCHB) provides 
funding to address some of the most urgent issues influencing the high 
rates of maternal mortality. Recent efforts to address persistent 
disparities in maternal, infant, and child health have employed a 
``life course'' perspective and health equity lens focused on health 
promotion and disease prevention. Life course approach can be defined 
as analyzing people's lives within structural, social, and cultural 
contexts through a defined sequence of age categories that people are 
normally expected to pass through as they progress from birth to death. 
Health equity is defined as the attainment of the highest level of 
health for all people.
    Achieving health equity for pregnant and postpartum women will 
require attention to barriers in access to quality health services and 
promotion of equal opportunities to seek the highest possible level of 
health and well-being. Achieving health equity also requires a focus on 
social determinants of health.
    With this emphasis on improving maternal health across the life 
course and promoting optimal health for all mothers, HRSA is employing 
a multipronged strategy to address maternal mortality and severe 
maternal morbidity through the following suite of programs:
    1. The State Maternal Health Innovation Program;

[[Page 66570]]

    2. The Alliance for Innovation on Maternal Health Program:
    3. The Alliance for Innovation on Maternal Health--Community Care 
Initiative;
    4. The Rural Maternity and Obstetrics Management Strategies 
Program; and,
    5. The Supporting Maternal Health Innovation Program.
    MCHB is conducting a portfolio-wide evaluation of HRSA-supported 
Maternal Health (MH) Programs with a primary focus on reducing maternal 
mortality. Through this evaluation, MCHB seeks to identify individual 
and/or collective strategies, interrelated activities, and common 
themes within and across the MH Programs that may be contributing to or 
driving improvements in key maternal health outcomes. MCHB seeks to 
ascertain which components should be elevated and replicated to the 
national level, as well as inform future investments to reduce rates of 
maternal mortality and severe maternal morbidity.
    A 60-day notice was published in the Federal Register on June 8, 
2020, vol. 85, No. 110; pp. 34739-40. There were no public comments.
    Need and Proposed Use of the Information: MCHB seeks to understand 
the impact of HRSA's investments in MH programs. These five programs 
represent a total of 12 state-based programs and three programs with 
the potential for national reach. In understanding the strategies that 
are most effective in reducing maternal morbidity and mortality, 
program elements could be replicated and/or scaled up nationally.
    Likely Respondents: Likely respondents are recipients of the 
cooperative agreements mentioned above (The State Maternal Health 
Innovation Program; The Alliance for Innovation on Maternal Health 
Program; The Alliance for Innovation on Maternal Health--Community Care 
Initiative; The Rural Maternity and Obstetrics Management Strategies 
Program; and, The Supporting Maternal Health Innovation Program) which 
represents 11 state health agencies, two national organizations, and 
two academic organizations.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install, and utilize technology and 
systems for the purpose of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                      Number                      Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Instrument 1: Interview guide                 75               1              75            1.00            75.0
 for grantee staff..............
Instrument 2: Interview guide                  7               1               7            1.50            10.5
 for HRSA POs...................
Instrument 3: Partnership Survey             290               1             290            0.25            72.5
Instrument 4: Web-based data                  15               1              15            0.50             7.5
 collection tool................
                                 -------------------------------------------------------------------------------
    Total.......................             387  ..............             387  ..............           165.5
----------------------------------------------------------------------------------------------------------------

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-23114 Filed 10-19-20; 8:45 am]
BILLING CODE 4165-15-P