Proposed Data Collection Submitted for Public Comment and Recommendations, 39911-39913 [2020-14332]

Download as PDF 39911 Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices health outcomes, including opioid overdose, sexual assault, and suicide attempts. The nature and consequences of ACEs in Tribal communities is unique because of historical trauma and stark socioeconomic disparities. In addition, there are gaps in the provision of adequate healthcare. This collection addresses critical research gaps and extends efforts to prevent violence and other ACEs before they occur and to build evidence of effectiveness of community-level strategies and approaches at the outer levels of the social ecology to Tribal communities. Results from this data (three urban and three rural) in regions identified with higher opioid overdose mortality rates relatively to other areas in Indian Country. Due to COVID–19, at the time of the focus groups/interviews, social distancing and public health safety measures will be implemented, including considerations for phone/ virtual meetings instead of in-person sessions. The total estimated annualized burden hours are 918. There are no costs to respondents other than their time. collection will be communicated to relevant public health officials and community stakeholders in the study locations. These local public health officials and community stakeholders will use the study results to guide strategies to further strengthen their local prevention efforts within their regions. Data collection methods used in this study include well-established qualitative methods, including in-depth open-ended individual interviews and focus groups. Quantitative methods include brief structured surveys. There will be a total of six Tribal communities ESTIMATED ANNUALIZED BURDEN HOURS Adults 18 years or older affected by the opioid epidemic living in Tribal urban and rural communities. Information Letter ................. Telephone screening ............ Confirmation email/letter ....... Reminder email .................... Informed Consent ................. Survey ................................... Focus group/interview .......... 336 336 252 252 252 252 252 1 1 1 1 1 1 1 5/60 20/60 3/60 2/60 15/60 45/60 2 28 112 13 9 63 189 504 Total ................................................ ............................................... ........................ ........................ ........................ 918 [FR Doc. 2020–14331 Filed 7–1–20; 8:45 am] BILLING CODE 4163–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES proposed information collection project titled Oral Health Basic Screening Survey for Children. The project provides state-specific data on dental caries (tooth decay) and dental sealants from a state-representative sample of elementary school children or children enrolled in Head Start programs and has been used by states to monitor oral health status of children and evaluate public health programs and policies. Centers for Disease Control and Prevention DATES: [60Day–20–20PM; Docket No. CDC–2020– 0072] ADDRESSES: Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Average burden per response (in hours) Data collection Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 Number of respondents Number of responses per respondent Type of respondents CDC must receive written comments on or before August 31, 2020. You may submit comments, identified by Docket No. CDC–2020– 0072 by any of the following methods: • Federal eRulemaking Portal: https:// www.Regulations.gov. Follow the instructions for submitting comments. • Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS–D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to https:// www.regulations.gov/. Please note: Submit all comments through the Federal eRulemaking portal (https:// www.regulations.gov) or by U.S. mail to the address listed above. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Total burden (in hours) To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS– D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the FOR FURTHER INFORMATION CONTACT: E:\FR\FM\02JYN1.SGM 02JYN1 39912 Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project Oral Health Basic Screening Survey for Children—Existing Collection in Use Without an OMB Control Number— National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC) Background and Brief Description Dental caries (tooth decay) is one of the most common chronic diseases among children in the United States and can lead to pain, infection, and diminished quality of life throughout the lifespan. Dental sealants are a costeffective measure to prevent caries but remain underutilized. To address states’ critical need for state-level oral health surveillance data on dental caries and sealants, the Association of State and Territorial Dental Directors (ASTDD) developed and released an oral health screening survey protocol referred to as the Basic Screening Survey (BSS) in 1999 in collaboration with the Ohio Department of Health and with technical assistance from the CDC’s Division of Oral Health. states currently funded by CDC, will conduct one BSS, at least for third grade, during the period for which this approval is being sought. State health departments administer the survey by determining probability samples, arranging logistics with selected schools or Head Start sites, gaining consent, obtaining demographic data, training screeners, conducting the oral health screening at schools or Head Start sites. Screeners record four data points either electronically or on a paper form: (1) Presence of treated caries, (2) presence of untreated tooth decay, (3) urgency of need for treatment, and (4) presence of dental sealants on at least one permanent molar tooth. State programs enter, clean and analyze the data; de-identify it; and respond to ASTDD’s annual email request for state-aggregated prevalence of dental caries and sealants. ASTDD reviews the data to ensure that both survey design and data meet specific criteria before sending it to CDC for publication on the CDC’s public-facing Oral Health Data website (https:// www.cdc.gov/oralhealthdata). BSS for children serves as a key state oral health surveillance data source and facilitates state capacity to (1) monitor children’s oral health status, trends, and disparities, and compare with other states; (2) inform planning, implementation and evaluation of effective oral health programs and policies; (3) measure state progress toward Healthy People objectives; and (4) educate the public and policy makers regarding cross-cutting public health programs. CDC also uses the data to evaluate performance of CDC oral health funding recipients. There are no costs to children respondents except their time. The estimated total annualized burden hours for the survey across the 34 states over the three years of this request are 40,207 with an average of 1,183 per state. BSS is a non-invasive visual observation of the mouth performed by trained screeners including dental and non-dental health professionals (e.g., dentists, hygienists, school nurses). The BSS data collection is not duplicative of any other federal collection. Though the National Health and Nutrition Examination Survey (NHANES) collects national data on oral health status including dental caries and sealants based on clinical examination, it is not designed to provide state-level data. BSS is designed to be easy to perform, while being consistent and aligned with the oral health Healthy People objectives, which are based on NHANES measures. BSS is the only data source that provides state-representative data on oral health status based on clinical examination. BSS is also used to monitor state progress toward key national oral health objectives. The BSS is a state-tailored survey administered and conducted by individual states. CDC has supported some of the 50 states to build and maintain their oral health surveillance system and ASTDD to provide technical assistance to states through state and partner cooperative agreements since 2001. Conducting BSS for third graders is a key component of that support. The target populations include school children in grades K–3 and children enrolled in Head Start in 50 states and Washington, DC. ASTDD and CDC recommend that states conduct BSS at minimum for third graders at least once every five years. Individual states determine how often to conduct BSS and which grade or grades to target based on their program needs and available resources. Forty-seven states have conducted BSS for children, and all 47 conducted third grade BSS. Thirty-two states also have conducted BSS in one or more other grades (K–2) or in Head Start. CDC estimates that approximately 34 states, including 20 khammond on DSKJM1Z7X2PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Child .................................................. Parent/caretaker ................................ Screener ............................................ School/site ......................................... State Official ...................................... Screening form ................................. Consent ............................................ Screening form ................................. Participation form ............................. Data Submission form ...................... 150,370 150,370 301 2,890 34 1 1 1 1 1 5/60 1/60 666/60 68/60 32,742/60 12,531 2,506 3,341 3,275 18,554 Total ........................................... ........................................................... ........................ ........................ ........................ 40,207 VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\02JYN1.SGM 02JYN1 Federal Register / Vol. 85, No. 128 / Thursday, July 2, 2020 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–14332 Filed 7–1–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1360] Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ZECUITY (sumatriptan iontophoretic transdermal system) held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. Teva requested withdrawal of this application and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of July 2, 2020. FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg., 51, Rm. 6226, Silver Spring, MD 20993–0002, 301– 796–3137. SUPPLEMENTARY INFORMATION: On January 17, 2013, FDA approved NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults. On June 2, 2016, FDA issued a Drug Safety Communication announcing the FDA is investigating the risk of serious burns and potential permanent scarring with the use of ZECUITY for migraine headaches. (https://www.fda.gov/drugs/ drug-safety-and-availability/fda-drugsafety-communication-fda-evaluatingrisk-burns-and-scars-ZECUITYsumatriptan-migraine-patch). On June 10, 2016, Teva suspended sales, marketing and distribution to investigate the cause of burns and scars associated with ZECUITY. On July 19, 2019, Teva requested withdrawal of NDA 202278 for ZECUITY under § 314.150(d) (21 CFR 314.150(d)) and waived its opportunity for a hearing. In its letter requesting khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 21:18 Jul 01, 2020 Jkt 250001 withdrawal of approval, Teva stated that it voluntarily discontinued manufacture and sale of products under NDA 202278 in 2016 for commercial reasons and has agreed to withdrawal of the application for those reasons only. For the reasons discussed above, and pursuant to the applicant’s request, approval of NDA 202278 for ZECUITY (sumatriptan iontophoretic transdermal system), and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of ZECUITY into interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Dated: June 22, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–14284 Filed 7–1–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0583] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by August 3, 2020. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted 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. The OMB control number for this information collection is 0910–0053. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 39913 Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: Radioactive Drug Research Committees—21 CFR 361.1 OMB Control Number 0910–0053— Extension Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. This information collection request supports those regulations. Specifically, § 361.1 (21 CFR 361.1) sets forth specific regulations about establishing and composing radioactive drug research committees (RDRCs) and their role in approving and monitoring basic research studies using radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulations and include studies of metabolism, human physiology, pathophysiology, or biochemistry. Section 361.1(c)(2) requires that each RDRC will select a chairman, who will sign all applications, minutes, and reports of the committee. Each committee will meet at least once each quarter in which research activity has been authorized or conducted. Minutes will be kept and will include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC will submit an annual report to FDA. The annual report will include the names and qualifications of the members of and of any consultants used by the RDRC, using Form FDA 2914 entitled ‘‘Radioactive Drug Research Committee Report on Research Use of Radioactive Drugs Membership Summary.’’ The annual report will also include a summary of each study conducted during the preceding year, using Form E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39911-39913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14332]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20PM; Docket No. CDC-2020-0072]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

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

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Oral Health Basic Screening 
Survey for Children. The project provides state-specific data on dental 
caries (tooth decay) and dental sealants from a state-representative 
sample of elementary school children or children enrolled in Head Start 
programs and has been used by states to monitor oral health status of 
children and evaluate public health programs and policies.

DATES: CDC must receive written comments on or before August 31, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0072 by any of the following methods:
     Federal eRulemaking Portal: https://www.Regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to https://www.regulations.gov/.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (https://www.regulations.gov) or by U.S. mail to 
the address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the

[[Page 39912]]

functions of the agency, including whether the information will have 
practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

Oral Health Basic Screening Survey for Children--Existing Collection in 
Use Without an OMB Control Number--National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control 
and Prevention (CDC)

Background and Brief Description
    Dental caries (tooth decay) is one of the most common chronic 
diseases among children in the United States and can lead to pain, 
infection, and diminished quality of life throughout the lifespan. 
Dental sealants are a cost-effective measure to prevent caries but 
remain underutilized.
    To address states' critical need for state-level oral health 
surveillance data on dental caries and sealants, the Association of 
State and Territorial Dental Directors (ASTDD) developed and released 
an oral health screening survey protocol referred to as the Basic 
Screening Survey (BSS) in 1999 in collaboration with the Ohio 
Department of Health and with technical assistance from the CDC's 
Division of Oral Health.
    BSS is a non-invasive visual observation of the mouth performed by 
trained screeners including dental and non-dental health professionals 
(e.g., dentists, hygienists, school nurses). The BSS data collection is 
not duplicative of any other federal collection. Though the National 
Health and Nutrition Examination Survey (NHANES) collects national data 
on oral health status including dental caries and sealants based on 
clinical examination, it is not designed to provide state-level data. 
BSS is designed to be easy to perform, while being consistent and 
aligned with the oral health Healthy People objectives, which are based 
on NHANES measures. BSS is the only data source that provides state-
representative data on oral health status based on clinical 
examination. BSS is also used to monitor state progress toward key 
national oral health objectives.
    The BSS is a state-tailored survey administered and conducted by 
individual states. CDC has supported some of the 50 states to build and 
maintain their oral health surveillance system and ASTDD to provide 
technical assistance to states through state and partner cooperative 
agreements since 2001. Conducting BSS for third graders is a key 
component of that support.
    The target populations include school children in grades K-3 and 
children enrolled in Head Start in 50 states and Washington, DC. ASTDD 
and CDC recommend that states conduct BSS at minimum for third graders 
at least once every five years. Individual states determine how often 
to conduct BSS and which grade or grades to target based on their 
program needs and available resources. Forty-seven states have 
conducted BSS for children, and all 47 conducted third grade BSS. 
Thirty-two states also have conducted BSS in one or more other grades 
(K-2) or in Head Start. CDC estimates that approximately 34 states, 
including 20 states currently funded by CDC, will conduct one BSS, at 
least for third grade, during the period for which this approval is 
being sought.
    State health departments administer the survey by determining 
probability samples, arranging logistics with selected schools or Head 
Start sites, gaining consent, obtaining demographic data, training 
screeners, conducting the oral health screening at schools or Head 
Start sites. Screeners record four data points either electronically or 
on a paper form: (1) Presence of treated caries, (2) presence of 
untreated tooth decay, (3) urgency of need for treatment, and (4) 
presence of dental sealants on at least one permanent molar tooth.
    State programs enter, clean and analyze the data; de-identify it; 
and respond to ASTDD's annual email request for state-aggregated 
prevalence of dental caries and sealants. ASTDD reviews the data to 
ensure that both survey design and data meet specific criteria before 
sending it to CDC for publication on the CDC's public-facing Oral 
Health Data website (https://www.cdc.gov/oralhealthdata).
    BSS for children serves as a key state oral health surveillance 
data source and facilitates state capacity to (1) monitor children's 
oral health status, trends, and disparities, and compare with other 
states; (2) inform planning, implementation and evaluation of effective 
oral health programs and policies; (3) measure state progress toward 
Healthy People objectives; and (4) educate the public and policy makers 
regarding cross-cutting public health programs. CDC also uses the data 
to evaluate performance of CDC oral health funding recipients.
    There are no costs to children respondents except their time. The 
estimated total annualized burden hours for the survey across the 34 
states over the three years of this request are 40,207 with an average 
of 1,183 per state.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Child.........................  Screening form..         150,370               1            5/60          12,531
Parent/caretaker..............  Consent.........         150,370               1            1/60           2,506
Screener......................  Screening form..             301               1          666/60           3,341
School/site...................  Participation              2,890               1           68/60           3,275
                                 form.
State Official................  Data Submission               34               1       32,742/60          18,554
                                 form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          40,207
----------------------------------------------------------------------------------------------------------------



[[Page 39913]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-14332 Filed 7-1-20; 8:45 am]
BILLING CODE 4163-18-P


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