Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Healthy Start Evaluation and Capacity Building Support, OMB No. 0906-xxxx-New, 78112-78114 [2022-27698]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 78112 Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Michelle Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993–0002, 240– 402–0374, Michelle.Weiner@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but it must be made prior to FDA’s approval of an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, is the subject of NDA 020711, held by GlaxoSmithKline LLC, VerDate Sep<11>2014 19:56 Dec 20, 2022 Jkt 259001 and initially approved on May 14, 1997. ZYBAN is indicated as an aid to smoking cessation treatment. ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Yichang Humanwell Pharmaceutical Co., Ltd. submitted a citizen petition dated April 18, 2022 (Docket No. FDA– 2022–P–0614), under 21 CFR 10.30, requesting that the Agency determine whether ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that this drug product was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Dated: December 15, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–27647 Filed 12–20–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Healthy Start Evaluation and Capacity Building Support, 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. SUMMARY: Comments on this ICR must be received no later than January 20, 2023. 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 Samantha Miller, the acting HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call 301–594– 4394. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Healthy Start Evaluation and Capacity Building Support, OMB No. 0906– xxxx—New. Abstract: The National Healthy Start Program, authorized by 42 U.S.C. 254c– 8 (section 330H of the Public Health Service Act) and funded through HRSA, has the goal of reducing disparities in DATES: E:\FR\FM\21DEN1.SGM 21DEN1 78113 Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices maternal and infant health. The program began as a demonstration project with 15 grantees in 1991 and has expanded over the past 3 decades to 101 grantees across 35 states; Washington, DC; and Puerto Rico. Healthy Start grantees operate in communities with rates of infant mortality at least 1.5 times the U.S. national average, or with high rates of other adverse perinatal outcomes (e.g., low birthweight, preterm birth). Grantees may also qualify for the program if their project areas meet other relevant criteria (e.g., high rates of diabetes, obesity, or tobacco use during pregnancy; low utilization of prenatal care in the first trimester; no utilization of prenatal care during pregnancy) that demonstrate disparities in health outcomes for pregnant women in their communities. Healthy Start programs are located in communities that are geographically, racially, ethnically, and linguistically diverse. Healthy Start covers services during the perinatal period (before, during, after pregnancy) and follows the women, infants, and fathers/partners in the program through 18 months after the end of the pregnancy. The Healthy Start program uses a life course approach that includes women’s health, family health and wellness, and community/population health. HRSA seeks to implement a mixedmethods evaluation to assess the effectiveness of the program on individual, organizational, and community-level outcomes. Data collection instruments will include the (1) Healthy Start Program Survey, (2) Healthy Start Network Survey, (3) Healthy Start Participant Survey, and (4) Healthy Start Stakeholder Interview Guide. These instruments have been specifically designed to be nonduplicative. Using previously approved content, the Healthy Start Program Survey is designed to collect information on the experiences of all 101 grantee programs related to program infrastructure, services/activities, participants, community partnerships, new maternal and fatherhood initiatives, and health equity. The information collected in the survey will allow the Healthy Start grantees to better assess risk, identify needed services, provide appropriate follow-up activities to program participants, and improve overall service delivery and quality. The two other surveys and interview guide will be administered to a subset of 15 grantees, their community partners, and participants. The Healthy Start Network Survey focuses on understanding the participation of members in the Healthy Start Community Action Networks (CANs) 1 and collaborations within the CANs to improve maternal, infant, and family outcomes within the Healthy Start communities. Results from the survey will help the Healthy Start programs and their CANs identify areas of strength and opportunities for further collaborations, understand how well the CAN members are working together to serve women and their families, and whether they are supporting the programs in addressing the participants’ greatest needs. The Healthy Start Participant Survey is designed to collect information about the experiences of the Healthy Start participants with the program and assess whether the programs are meeting their needs. The Healthy Start grantees can use this information to identify areas to strengthen the services provided to the participants. The Healthy Start Stakeholder Interview Guide is designed to collect more in-depth information about the Healthy Start services, the new maternal health and fatherhood initiatives, CAN activities, and activities developed to improve the Healthy Start benchmarks and achieve health equity. A 60-day notice was published in the Federal Register, 87 FR 43535 (July 21, 2022). There were no public comments. Need and Proposed Use of the Information: The purpose of the data collection instruments is to obtain consistent information across all grantees about Healthy Start, its operations and outcomes. The data will be used to (1) conduct ongoing performance monitoring of the program; (2) provide credible and rigorous evidence of program effect on outcomes; (3) meet program needs for accountability, programmatic decisionmaking, and ongoing quality assurance; and (4) strengthen the evidence base and identify best and promising practices for the program to support sustainability, replication, and dissemination of the program. Likely Respondents: Respondents will include project directors and staff for the Healthy Start Program Survey, members of the CANs for the Healthy Start Network Survey, program participants for the Healthy Start Participant Survey, and program and administrative staff for the Healthy Start Stakeholder Interview Guide. 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 utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing 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. The total number of responses was multiplied by the average burden per response and summed to produce the total annualized burden hours, which is estimated to be 600 hours. A break-down of these hours is detailed in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents lotter on DSK11XQN23PROD with NOTICES1 Form name Healthy Healthy Healthy Healthy Start Start Start Start Program Survey ............................................. Network Survey ............................................. Participant Survey .......................................... Stakeholder Interview Guide ......................... Total .............................................................................. 1 This Number of responses per respondent 101 Total responses Average burden per response (in hours) Total burden hours 3 150 1 1 1 1 101 600 750 150 1.00 0.33 0.25 0.75 101 198 188 113 1,601 ........................ 1,601 ........................ 600 1 600 2 750 is the maximum number of responses for this data collection instrument. 1 A CAN is an existing, formally organized partnership of organizations and individuals. The CAN represents consumers and appropriate VerDate Sep<11>2014 19:56 Dec 20, 2022 Jkt 259001 agencies which unite in an effort to collectively apply their resources to the implementation of one PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 or more common strategies to achieve a common goal within that project area. E:\FR\FM\21DEN1.SGM 21DEN1 78114 Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices 2 Ibid. 3 Ibid. 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. 2022–27698 Filed 12–20–22; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Nurse Corps Loan Repayment Program; OMB No. 0915–0140 Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. SUMMARY: Comments on this ICR should be received no later than January 20, 2023. 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 Samantha Miller, the acting HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call 301–594– 4394. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Nurse Corps Loan Repayment Program (Nurse Corps LRP), OMB No. 0915– 0140—Extension. Abstract: The Nurse Corps LRP assists in the recruitment and retention of professional Registered Nurses (RNs), including Advanced Practice Registered Nurses (APRNs), by decreasing the financial barriers associated with pursuing a nursing education. RNs in this instance include APRNs (e.g., nurse practitioners, certified registered nurse anesthetists, certified nurse-midwives, and clinical nurse specialists) dedicated to working at eligible health care facilities with a critical shortage of nurses (i.e., a Critical Shortage Facility) or working as nurse faculty in eligible, accredited schools of nursing. The Nurse Corps LRP provides loan repayment assistance to these nurses to repay a portion of their qualifying educational loans in exchange for fulltime service at a public or private DATES: Critical Shortage Facility or in an eligible, accredited school of nursing. A 60-day notice published in the Federal Register on September 29, 2022, vol. 87, No. 188; pp. 59106–07. There were no public comments. Need and Proposed Use of the Information: Individuals must submit an application in order to participate in the program. The application asks for personal, professional, educational, and financial information required to determine the applicant’s eligibility to participate in the Nurse Corps LRP. This information collection is used by the Nurse Corps program to make award decisions about Nurse Corps LRP applicants and to monitor a participant’s compliance with the program’s service requirements. The Nurse Corps LRP is requesting an extension and is seeking to use the previously approved forms. Likely Respondents: Professional RNs or APRNs who are interested in participating in the Nurse Corps LRP, and official representatives at their service sites. 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 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 lotter on DSK11XQN23PROD with NOTICES1 Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Nurse Corps LRP Application * ............................................ Authorization to Release Information Form ** ..................... Employment Verification Form ** ......................................... Disadvantaged Background Form ....................................... Confirmation of Interest Form .............................................. 7,100 7,100 7,100 450 500 1 1 1 1 1 7,100 7,100 7,100 450 500 2.00 .10 .10 .20 .20 14,200 710 710 90 100 Total for Applicants ....................................................... 22,250 ........................ 22,250 ........................ 15,810 * The burden hours associated with this instrument account for both new and continuation applications. Additional (uploaded) supporting documentation is included as part of this instrument and reflected in the burden hours. ** The same respondents are completing these instruments. VerDate Sep<11>2014 19:56 Dec 20, 2022 Jkt 259001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78112-78114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27698]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Healthy 
Start Evaluation and Capacity Building Support, 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 must be received no later than January 20, 
2023.

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 Samantha Miller, the acting 
HRSA Information Collection Clearance Officer at [email protected] or 
call 301-594-4394.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Healthy Start Evaluation and 
Capacity Building Support, OMB No. 0906-xxxx--New.
    Abstract: The National Healthy Start Program, authorized by 42 
U.S.C. 254c-8 (section 330H of the Public Health Service Act) and 
funded through HRSA, has the goal of reducing disparities in

[[Page 78113]]

maternal and infant health. The program began as a demonstration 
project with 15 grantees in 1991 and has expanded over the past 3 
decades to 101 grantees across 35 states; Washington, DC; and Puerto 
Rico. Healthy Start grantees operate in communities with rates of 
infant mortality at least 1.5 times the U.S. national average, or with 
high rates of other adverse perinatal outcomes (e.g., low birthweight, 
preterm birth). Grantees may also qualify for the program if their 
project areas meet other relevant criteria (e.g., high rates of 
diabetes, obesity, or tobacco use during pregnancy; low utilization of 
prenatal care in the first trimester; no utilization of prenatal care 
during pregnancy) that demonstrate disparities in health outcomes for 
pregnant women in their communities. Healthy Start programs are located 
in communities that are geographically, racially, ethnically, and 
linguistically diverse. Healthy Start covers services during the 
perinatal period (before, during, after pregnancy) and follows the 
women, infants, and fathers/partners in the program through 18 months 
after the end of the pregnancy. The Healthy Start program uses a life 
course approach that includes women's health, family health and 
wellness, and community/population health.
    HRSA seeks to implement a mixed-methods evaluation to assess the 
effectiveness of the program on individual, organizational, and 
community-level outcomes. Data collection instruments will include the 
(1) Healthy Start Program Survey, (2) Healthy Start Network Survey, (3) 
Healthy Start Participant Survey, and (4) Healthy Start Stakeholder 
Interview Guide. These instruments have been specifically designed to 
be non-duplicative. Using previously approved content, the Healthy 
Start Program Survey is designed to collect information on the 
experiences of all 101 grantee programs related to program 
infrastructure, services/activities, participants, community 
partnerships, new maternal and fatherhood initiatives, and health 
equity. The information collected in the survey will allow the Healthy 
Start grantees to better assess risk, identify needed services, provide 
appropriate follow-up activities to program participants, and improve 
overall service delivery and quality.
    The two other surveys and interview guide will be administered to a 
subset of 15 grantees, their community partners, and participants. The 
Healthy Start Network Survey focuses on understanding the participation 
of members in the Healthy Start Community Action Networks (CANs) \1\ 
and collaborations within the CANs to improve maternal, infant, and 
family outcomes within the Healthy Start communities. Results from the 
survey will help the Healthy Start programs and their CANs identify 
areas of strength and opportunities for further collaborations, 
understand how well the CAN members are working together to serve women 
and their families, and whether they are supporting the programs in 
addressing the participants' greatest needs. The Healthy Start 
Participant Survey is designed to collect information about the 
experiences of the Healthy Start participants with the program and 
assess whether the programs are meeting their needs. The Healthy Start 
grantees can use this information to identify areas to strengthen the 
services provided to the participants. The Healthy Start Stakeholder 
Interview Guide is designed to collect more in-depth information about 
the Healthy Start services, the new maternal health and fatherhood 
initiatives, CAN activities, and activities developed to improve the 
Healthy Start benchmarks and achieve health equity.
---------------------------------------------------------------------------

    \1\ A CAN is an existing, formally organized partnership of 
organizations and individuals. The CAN represents consumers and 
appropriate agencies which unite in an effort to collectively apply 
their resources to the implementation of one or more common 
strategies to achieve a common goal within that project area.
---------------------------------------------------------------------------

    A 60-day notice was published in the Federal Register, 87 FR 43535 
(July 21, 2022). There were no public comments.
    Need and Proposed Use of the Information: The purpose of the data 
collection instruments is to obtain consistent information across all 
grantees about Healthy Start, its operations and outcomes. The data 
will be used to (1) conduct ongoing performance monitoring of the 
program; (2) provide credible and rigorous evidence of program effect 
on outcomes; (3) meet program needs for accountability, programmatic 
decision-making, and ongoing quality assurance; and (4) strengthen the 
evidence base and identify best and promising practices for the program 
to support sustainability, replication, and dissemination of the 
program.
    Likely Respondents: Respondents will include project directors and 
staff for the Healthy Start Program Survey, members of the CANs for the 
Healthy Start Network Survey, program participants for the Healthy 
Start Participant Survey, and program and administrative staff for the 
Healthy Start Stakeholder Interview Guide.
    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 utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing 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. The total number of responses was multiplied by the 
average burden per response and summed to produce the total annualized 
burden hours, which is estimated to be 600 hours. A break-down of these 
hours is detailed in the table below.

                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Healthy Start Program Survey....             101               1             101            1.00             101
Healthy Start Network Survey....         \1\ 600               1             600            0.33             198
Healthy Start Participant Survey         \2\ 750               1             750            0.25             188
Healthy Start Stakeholder                \3\ 150               1             150            0.75             113
 Interview Guide................
                                 -------------------------------------------------------------------------------
    Total.......................           1,601  ..............           1,601  ..............             600
----------------------------------------------------------------------------------------------------------------
\1\ This is the maximum number of responses for this data collection instrument.

[[Page 78114]]

 
\2\ Ibid.
\3\ Ibid.

    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. 2022-27698 Filed 12-20-22; 8:45 am]
BILLING CODE 4165-15-P


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