83_FR_50291 83 FR 50098 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 50098 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 193 (October 4, 2018)

Page Range50098-50099
FR Document2018-21571

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 revision of information collection project titled Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas. This revision is to allow CDC to continue collecting the information needed to assess the effectiveness of its program, ``Scaling the National DPP in Underserved Areas'', and to collect more targeted information on CDC grantees' success in reaching both general and priority populations in underserved areas.

Federal Register, Volume 83 Issue 193 (Thursday, October 4, 2018)
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50098-50099]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-18-1090; Docket No. CDC-2018-0089]


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 
revision of information collection project titled Formative and 
Summative Evaluation of Scaling the National Diabetes Prevention 
Program (National DPP) in Underserved Areas. This revision is to allow 
CDC to continue collecting the information needed to assess the 
effectiveness of its program, ``Scaling the National DPP in Underserved 
Areas'', and to collect more targeted information on CDC grantees' 
success in reaching both general and priority populations in 
underserved areas.

DATES: CDC must receive written comments on or before December 3, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0089 by any of the following methods:
     Federal eRulemaking Portal: 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 Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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: 
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 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

    Formative and Summative Evaluation of Scaling the National Diabetes 
Prevention Program in Underserved Areas (OMB No. 0920-1090, exp. 12/31/
2018)--Revision--National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The CDC-led National Diabetes Prevention Program (National DPP) is 
a partnership of public and private organizations working collectively 
to build the infrastructure for nationwide delivery of an evidence-
based lifestyle change program to prevent or delay Type 2 diabetes 
among adults with prediabetes. The National DPP lifestyle change 
program is founded on the science of the Diabetes Prevention Program 
research study, and several translation studies that followed, which 
showed that making modest behavior changes helped people with 
prediabetes lose 5% to 7% of their body weight and reduce their risk of 
developing Type 2 diabetes by 58% (71% for people over 60 years old). 
From 2012 to 2017, CDC funded six national organizations through a 
cooperative agreement to establish and expand multistate networks of 
over 200 program delivery organizations that are able to meet national 
standards and achieve the outcomes proven to prevent or delay onset of 
Type 2 diabetes. CDC has conducted a formative and summative evaluation 
of this program and used the

[[Page 50099]]

evaluation findings and lessons learned to provide data-driven 
technical assistance to the grantees and other organizations delivering 
the National DPP lifestyle change program. The data and lessons learned 
from DP12-1212 were also used to inform decision-making and policy, 
including the development of the Centers for Medicare & Medicaid 
Services (CMS) Medicare Diabetes Prevention Program (MDPP). As of April 
1, 2018, the MDPP Expanded Model provides coverage for the National DPP 
lifestyle change program for eligible Medicare beneficiaries.
    Despite the fact that over 1800 CDC-recognized organizations in 50 
states, the District of Columbia, Puerto Rico, and the Virgin Islands 
offer the National DPP lifestyle change program, there are still many 
geographic areas with few or no in-person delivery programs. In 
addition, some populations, including Medicare beneficiaries, men, 
African-Americans, Asian-Americans, Hispanics, American Indians, Alaska 
Natives, Pacific Islanders, and people with visual impairment or 
physical disabilities, are under-enrolled relative to their estimated 
numbers and disease burden. To address these gaps, CDC funded a new, 
five-year cooperative agreement with ten new national organizations in 
September 2017, ``Scaling the National DPP in Underserved Areas'' 
(DP17-1705). CDC funded ten national organizations with affiliate 
program delivery sites in at least three states, each to start new CDC-
recognized organizations in underserved areas and to enroll both 
general and priority populations in new or existing CDC-recognized 
organizations. The DP17-1705 grantees will work on activities designed 
to accomplish three main goals:
    (1) Build the infrastructure in underserved areas necessary to 
deliver the National DPP lifestyle change program to the general 
population and to priority populations, including Medicare 
beneficiaries, men, African-Americans, Asian-Americans, Hispanics, 
American Indians, Alaska Natives, Pacific Islanders, and non-
institutionalized people with visual or physical disabilities;
    (2) Tailor and adapt the program to address the unique needs and 
challenges of the enrolled participants; and
    (3) Provide participants with specialized support needed to 
successfully complete the program and achieve 5-7% weight loss. Through 
this new cooperative agreement, it is anticipated that enrollment, 
retention, and achievement of 5-7% weight loss goals for the targeted 
populations will increase.
    At this time, CDC requests an additional three years of OMB 
approval to continue collecting information needed to evaluate the 
effectiveness of CDC's funding for the new grantees. The data 
collection will allow CDC to continue to provide data-driven, tailored 
programmatic technical assistance to ensure continuous quality 
improvement for each year of the cooperative agreement. A number of 
changes to the evaluation forms are proposed to ensure that reporting 
and evaluation requirements are consistent with the aims of the new 
cooperative agreement and reflect the lessons learned from the original 
funded national organizations and their affiliate delivery sites. 
Evaluation data elements have been added or modified accordingly. Also, 
the method of data collection has converted from using an Excel 
spreadsheet to a web-based data system to allow for real-time feedback 
and technical assistance.
    The reporting burden of this collection of information is estimated 
to vary between two and four hours with an average of three hours per 
grantee response (decreased from 12 hours), and between four and six 
hours with an average of five hours per affiliate delivery site 
response (increased from an average of 45 minutes per response). These 
estimated burden hours include the time for reviewing instructions, 
searching existing data sources, gathering and maintaining the data 
needed, and completing and reviewing the collection of information by 
the grantee and affiliate delivery site to submit information directly 
to the web-based data system. The number of respondents will increase 
with the increased number of grantees. These changes result in a net 
increase of 368 annualized burden hours. There are no costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
National DPP Affiliate          Evaluation Form              100               1               5             500
 Delivery Sites.                 for Sites.
National DPP Grantees.........  Evaluation Form               10               1               3              30
                                 for Grantees.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             530
----------------------------------------------------------------------------------------------------------------



Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-21571 Filed 10-3-18; 8:45 am]
BILLING CODE 4163-18-P



                                               50098                               Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices

                                                                                                         ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                     Average                     Average
                                                                                                                                                                        Number of                   number of                  burden per              Total burden
                                                               Respondents                                                      Forms                                  respondents               responses per                  response                  hours
                                                                                                                                                                                                   respondent                    (hours)

                                                                                                        Surge Event Testing Results ...........                                        130                         625                          24        1,950,000

                                                    Total ...........................................   ...........................................................   ........................   ........................   ........................      2,064,660



                                               Jeffrey M. Zirger,                                                         • Federal eRulemaking Portal:                                              proposed collection of information,
                                               Acting Chief, Information Collection Review                             Regulations.gov. Follow the instructions                                      including the validity of the
                                               Office, Office of Scientific Integrity, Office                          for submitting comments.                                                      methodology and assumptions used;
                                               of the Associate Director for Science, Office                              • Mail: Jeffrey M. Zirger, Information                                       3. Enhance the quality, utility, and
                                               of the Director, Centers for Disease Control                            Collection Review Office, Centers for                                         clarity of the information to be
                                               and Prevention.                                                                                                                                       collected; and
                                                                                                                       Disease Control and Prevention, 1600
                                               [FR Doc. 2018–21570 Filed 10–3–18; 8:45 am]                             Clifton Road NE, MS–D74, Atlanta,                                               4. Minimize the burden of the
                                               BILLING CODE 4163–18–P                                                  Georgia 30329.                                                                collection of information on those who
                                                                                                                          Instructions: All submissions received                                     are to respond, including through the
                                                                                                                       must include the agency name and                                              use of appropriate automated,
                                               DEPARTMENT OF HEALTH AND                                                Docket Number. CDC will post, without                                         electronic, mechanical, or other
                                               HUMAN SERVICES                                                          change, all relevant comments to                                              technological collection techniques or
                                                                                                                       Regulations.gov.                                                              other forms of information technology,
                                               Centers for Disease Control and                                                                                                                       e.g., permitting electronic submissions
                                               Prevention                                                                 Please note: Submit all comments
                                                                                                                       through the Federal eRulemaking portal                                        of responses.
                                               [60 Day–18–1090; Docket No. CDC–2018–                                   (regulations.gov) or by U.S. mail to the                                        5. Assess information collection costs.
                                               0089]                                                                   address listed above.                                                         Proposed Project
                                                                                                                       FOR FURTHER INFORMATION CONTACT: To
                                               Proposed Data Collection Submitted                                                                                                                      Formative and Summative Evaluation
                                               for Public Comment and                                                  request more information on the                                               of Scaling the National Diabetes
                                               Recommendations                                                         proposed project or to obtain a copy of                                       Prevention Program in Underserved
                                                                                                                       the information collection plan and                                           Areas (OMB No. 0920–1090, exp.
                                               AGENCY: Centers for Disease Control and                                 instruments, contact Jeffrey M. Zirger,                                       12/31/2018)—Revision—National
                                               Prevention (CDC), Department of Health                                  Information Collection Review Office,                                         Center for Chronic Disease Prevention
                                               and Human Services (HHS).                                               Centers for Disease Control and                                               and Health Promotion (NCCDPHP),
                                               ACTION: Notice with comment period.                                     Prevention, 1600 Clifton Road NE, MS–                                         Centers for Disease Control and
                                                                                                                       D74, Atlanta, Georgia 30329; phone:                                           Prevention (CDC).
                                               SUMMARY:   The Centers for Disease                                      404–639–7570; Email: omb@cdc.gov.
                                               Control and Prevention (CDC), as part of                                                                                                              Background and Brief Description
                                                                                                                       SUPPLEMENTARY INFORMATION: Under the
                                               its continuing effort to reduce public
                                               burden and maximize the utility of                                      Paperwork Reduction Act of 1995 (PRA)                                            The CDC-led National Diabetes
                                                                                                                       (44 U.S.C. 3501–3520), Federal agencies                                       Prevention Program (National DPP) is a
                                               government information, invites the
                                                                                                                       must obtain approval from the Office of                                       partnership of public and private
                                               general public and other Federal
                                                                                                                       Management and Budget (OMB) for each                                          organizations working collectively to
                                               agencies the opportunity to comment on
                                                                                                                       collection of information they conduct                                        build the infrastructure for nationwide
                                               a proposed and/or continuing
                                                                                                                       or sponsor. In addition, the PRA also                                         delivery of an evidence-based lifestyle
                                               information collection, as required by
                                                                                                                       requires Federal agencies to provide a                                        change program to prevent or delay
                                               the Paperwork Reduction Act of 1995.
                                                                                                                       60-day notice in the Federal Register                                         Type 2 diabetes among adults with
                                               This notice invites comment on a
                                                                                                                       concerning each proposed collection of                                        prediabetes. The National DPP lifestyle
                                               proposed revision of information
                                                                                                                       information, including each new                                               change program is founded on the
                                               collection project titled Formative and
                                                                                                                       proposed collection, each proposed                                            science of the Diabetes Prevention
                                               Summative Evaluation of Scaling the                                                                                                                   Program research study, and several
                                               National Diabetes Prevention Program                                    extension of existing collection of
                                                                                                                       information, and each reinstatement of                                        translation studies that followed, which
                                               (National DPP) in Underserved Areas.                                                                                                                  showed that making modest behavior
                                               This revision is to allow CDC to                                        previously approved information
                                                                                                                       collection before submitting the                                              changes helped people with prediabetes
                                               continue collecting the information                                                                                                                   lose 5% to 7% of their body weight and
                                               needed to assess the effectiveness of its                               collection to the OMB for approval. To
                                                                                                                       comply with this requirement, we are                                          reduce their risk of developing Type 2
                                               program, ‘‘Scaling the National DPP in                                                                                                                diabetes by 58% (71% for people over
                                               Underserved Areas’’, and to collect                                     publishing this notice of a proposed
                                                                                                                       data collection as described below.                                           60 years old). From 2012 to 2017, CDC
                                               more targeted information on CDC                                                                                                                      funded six national organizations
                                                                                                                          The OMB is particularly interested in
                                               grantees’ success in reaching both                                                                                                                    through a cooperative agreement to
                                                                                                                       comments that will help:
                                               general and priority populations in                                                                                                                   establish and expand multistate
                                                                                                                          1. Evaluate whether the proposed
daltland on DSKBBV9HB2PROD with NOTICES




                                               underserved areas.                                                                                                                                    networks of over 200 program delivery
                                                                                                                       collection of information is necessary
                                               DATES: CDC must receive written                                         for the proper performance of the                                             organizations that are able to meet
                                               comments on or before December 3,                                       functions of the agency, including                                            national standards and achieve the
                                               2018.                                                                   whether the information will have                                             outcomes proven to prevent or delay
                                               ADDRESSES: You may submit comments,                                     practical utility;                                                            onset of Type 2 diabetes. CDC has
                                               identified by Docket No. CDC–2018–                                         2. Evaluate the accuracy of the                                            conducted a formative and summative
                                               0089 by any of the following methods:                                   agency’s estimate of the burden of the                                        evaluation of this program and used the


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                                                                                   Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices                                                                                                50099

                                               evaluation findings and lessons learned                                 recognized organizations in underserved                                       improvement for each year of the
                                               to provide data-driven technical                                        areas and to enroll both general and                                          cooperative agreement. A number of
                                               assistance to the grantees and other                                    priority populations in new or existing                                       changes to the evaluation forms are
                                               organizations delivering the National                                   CDC-recognized organizations. The                                             proposed to ensure that reporting and
                                               DPP lifestyle change program. The data                                  DP17–1705 grantees will work on                                               evaluation requirements are consistent
                                               and lessons learned from DP12–1212                                      activities designed to accomplish three                                       with the aims of the new cooperative
                                               were also used to inform decision-                                      main goals:                                                                   agreement and reflect the lessons
                                               making and policy, including the                                           (1) Build the infrastructure in                                            learned from the original funded
                                               development of the Centers for                                          underserved areas necessary to deliver                                        national organizations and their affiliate
                                               Medicare & Medicaid Services (CMS)                                      the National DPP lifestyle change                                             delivery sites. Evaluation data elements
                                               Medicare Diabetes Prevention Program                                    program to the general population and                                         have been added or modified
                                               (MDPP). As of April 1, 2018, the MDPP                                   to priority populations, including                                            accordingly. Also, the method of data
                                               Expanded Model provides coverage for                                    Medicare beneficiaries, men, African-                                         collection has converted from using an
                                               the National DPP lifestyle change                                       Americans, Asian-Americans,                                                   Excel spreadsheet to a web-based data
                                               program for eligible Medicare                                           Hispanics, American Indians, Alaska                                           system to allow for real-time feedback
                                               beneficiaries.                                                          Natives, Pacific Islanders, and non-                                          and technical assistance.
                                                  Despite the fact that over 1800 CDC-                                 institutionalized people with visual or                                         The reporting burden of this
                                               recognized organizations in 50 states,                                  physical disabilities;                                                        collection of information is estimated to
                                               the District of Columbia, Puerto Rico,                                     (2) Tailor and adapt the program to                                        vary between two and four hours with
                                               and the Virgin Islands offer the National                               address the unique needs and                                                  an average of three hours per grantee
                                               DPP lifestyle change program, there are                                 challenges of the enrolled participants;                                      response (decreased from 12 hours), and
                                               still many geographic areas with few or                                 and                                                                           between four and six hours with an
                                               no in-person delivery programs. In                                         (3) Provide participants with                                              average of five hours per affiliate
                                               addition, some populations, including                                   specialized support needed to                                                 delivery site response (increased from
                                               Medicare beneficiaries, men, African-                                   successfully complete the program and                                         an average of 45 minutes per response).
                                               Americans, Asian-Americans,                                             achieve 5–7% weight loss. Through this                                        These estimated burden hours include
                                               Hispanics, American Indians, Alaska                                     new cooperative agreement, it is                                              the time for reviewing instructions,
                                               Natives, Pacific Islanders, and people                                  anticipated that enrollment, retention,                                       searching existing data sources,
                                               with visual impairment or physical                                      and achievement of 5–7% weight loss                                           gathering and maintaining the data
                                               disabilities, are under-enrolled relative                               goals for the targeted populations will                                       needed, and completing and reviewing
                                               to their estimated numbers and disease                                  increase.                                                                     the collection of information by the
                                               burden. To address these gaps, CDC                                         At this time, CDC requests an                                              grantee and affiliate delivery site to
                                               funded a new, five-year cooperative                                     additional three years of OMB approval                                        submit information directly to the web-
                                               agreement with ten new national                                         to continue collecting information                                            based data system. The number of
                                               organizations in September 2017,                                        needed to evaluate the effectiveness of                                       respondents will increase with the
                                               ‘‘Scaling the National DPP in                                           CDC’s funding for the new grantees. The                                       increased number of grantees. These
                                               Underserved Areas’’ (DP17–1705). CDC                                    data collection will allow CDC to                                             changes result in a net increase of 368
                                               funded ten national organizations with                                  continue to provide data-driven,                                              annualized burden hours. There are no
                                               affiliate program delivery sites in at                                  tailored programmatic technical                                               costs to respondents other than their
                                               least three states, each to start new CDC-                              assistance to ensure continuous quality                                       time.

                                                                                                                      ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                 Average
                                                                                                                                                                                                   Number of
                                                                 Type of                                                                                                Number of                                              burden per              Total burden
                                                                                                                            Form name                                                            responses per
                                                               respondents                                                                                             respondents                 respondent                   response                (in hours)
                                                                                                                                                                                                                                (in hours)

                                               National DPP Affiliate Delivery Sites                    Evaluation Form for Sites .................                                     100                            1                         5              500
                                               National DPP Grantees ....................               Evaluation Form for Grantees ..........                                          10                            1                         3               30

                                                    Total ...........................................   ...........................................................   ........................   ........................   ........................            530



                                               Jeffrey M. Zirger,                                                      DEPARTMENT OF HEALTH AND                                                      SUMMARY:   The Centers for Medicare &
                                               Acting Chief, Information Collection Review                             HUMAN SERVICES                                                                Medicaid Services (CMS) is announcing
                                               Office, Office of Scientific Integrity, Office                                                                                                        an opportunity for the public to
                                               of the Associate Director for Science, Office                           Centers for Medicare & Medicaid                                               comment on CMS’ intention to collect
                                               of the Director, Centers for Disease Control                            Services                                                                      information from the public. Under the
                                               and Prevention.                                                                                                                                       Paperwork Reduction Act of 1995 (the
                                                                                                                       [Document Identifier: CMS–10391]
                                               [FR Doc. 2018–21571 Filed 10–3–18; 8:45 am]                                                                                                           PRA), federal agencies are required to
                                               BILLING CODE 4163–18–P                                                  Agency Information Collection                                                 publish notice in the Federal Register
daltland on DSKBBV9HB2PROD with NOTICES




                                                                                                                       Activities: Proposed Collection;                                              concerning each proposed collection of
                                                                                                                       Comment Request                                                               information (including each proposed
                                                                                                                       AGENCY: Centers for Medicare &                                                extension or reinstatement of an existing
                                                                                                                       Medicaid Services, Department of                                              collection of information) and to allow
                                                                                                                       Health and Human Services.                                                    60 days for public comment on the
                                                                                                                                                                                                     proposed action. Interested persons are
                                                                                                                       ACTION: Notice.
                                                                                                                                                                                                     invited to send comments regarding our


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Document Created: 2018-10-04 02:03:16
Document Modified: 2018-10-04 02:03:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesCDC must receive written comments on or before December 3, 2018.
ContactTo 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]
FR Citation83 FR 50098 

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