83 FR 60868 - 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 228 (November 27, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 228 (November 27, 2018)
| Page Range | 60868-60870 | |
| FR Document | 2018-25752 |
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)] [Notices] [Pages 60868-60870] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25752] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-19-19BN; Docket No. CDC-2018-0104] 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 ``Emergency Cruise Ship Outbreak Investigations (CSOIs)''. The purpose of this study is to allow the CDC Vessel Sanitation Program (VSP) to prevent the introduction, transmission, or spread of acute gastroenteritis (AGE) via cruise ships entering the United States from foreign countries. DATES: CDC must receive written comments on or before January 28, 2019. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0104 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. [[Page 60869]] 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 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 Emergency Cruise Ship Outbreak Investigations (COIs)--Existing Collection in Use without an OMB Control Number--National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Background and Brief Description Established in 1975 as a cooperative activity with the cruise ship industry, the Centers for Disease Control and Prevention (CDC) Vessel Sanitation Program (VSP) develops and implements comprehensive sanitation programs to minimize the risk of gastrointestinal diseases, by coordinating and conducting operational inspections, ongoing surveillance of gastrointestinal illness, and outbreak investigations on vessels. Under the authority of the Public Health Service Act (42 U.S.C. Sections 264 and 269), the VSP is requesting a three-year approval for a new generic clearance information collection request (ICR). This ICR will provide the quick turn-around necessary to conduct emergency cruise ship outbreak investigations (CSOIs) in response to acute gastroenteritis (AGE) outbreaks. CSOIs are used to determine the causative agents and their sources, modes of transmission, or risk factors. The VSP's jurisdiction includes passenger vessels carrying 13 or more people sailing from foreign ports and within 15 days of arriving at a U.S. port. VSP uses its syndromic surveillance system called the Maritime Illness and Death Reporting System (MIDRS) (approved under ``Foreign Quarantine Regulations'' [OMB Control No. 0920-0134, expiration date 05/31/2019]) to collect aggregate data about the number of people onboard ships in VSP's jurisdiction who are experiencing AGE symptoms. When the levels of illness meet VSP's alert threshold (i.e., at least 2% in either the passenger or crew populations), a special report is made to VSP via MIDRS and remote environmental health and epidemiologic assistance is provided. VSP considers an outbreak to be >=3% of reportable AGE cases in either guest or crew populations. When assistance is needed due to AGE outbreaks on cruise ships, this often requires VSP to deploy a response team to meet the ship in port within 24 hours of reaching the outbreak threshold, and in some cases deploying the response team to board the ship before its U.S. arrival and sail back to the U.S. port of disembarkation to conduct a more detailed and comprehensive epidemiologic and environmental health evaluation of the outbreak. Causative agent, sources of exposure, modes of transmission, and risk factors can be ascertained by gathering the following types of information from both the affected and (seemingly) unaffected populations: Demographic information, Pre-embarkation travel information, Symptoms, including type, onset, duration, Contact with people who were sick or their body fluids, Participation in ship and shore activities, Locations of eating and drinking, and Foods and beverages consumed both on the ship and on shore. Rapid and flexible data collection is imperative given the mobile environment, the remaining duration of the voyage left for investigation, and the loss to follow-up if delays allow passengers to disembark and leave the ship, including those returning to locations outside of the U.S. This new generic clearance will cover investigations that meet all of the following criteria: The investigation is urgent in nature (i.e., timely data are needed to inform rapid public health action to prevent or reduce morbidity or mortality). The investigation is characterized by undetermined agents, undetermined sources, undetermined modes of transmission, or undetermined risk factors. One or more CDC staff (including trainees and fellows) will be deployed to the field. Most CSOIs involve two to five days of data collection; data collection is completed in 30 days or less. This new generic clearance excludes each of the following: Investigations related to non-urgent outbreaks or events. Investigations conducted for the primary purpose of program evaluation, surveillance, needs assessment, or research (e.g., to contribute to generalizable knowledge). Investigations with data collection expected for greater than 30 days. The VSP estimates 10 CSOIs annually in response to cruise ship AGE outbreaks. The estimated number of respondents is 2,500 per CSOI, for a total of 25,000 respondents per year. The average time burden is 15 minutes for each respondent. Therefore, the total estimated annual burden in hours is 6,250. There is no cost to respondents other than their time. [[Page 60870]] 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) ---------------------------------------------------------------------------------------------------------------- Cruise Ship Passengers or Crew Questionnaire... 24,750 1 15/60 6,188 Cruise Ship Passengers or Crew Interview....... 250 1 15/60 62 --------------------------------------------------------------------------------- Total..................... ................ .............. .............. .............. 6,250 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2018-25752 Filed 11-26-18; 8:45 am] BILLING CODE 4163-18-P
![60868 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
years old (76 hours); and 10 minutes for minutes for 1,440 adults (720 hours); 15 subset of households deemed eligible
191 children aged 12–17 years old who minutes for 264 parents responding for for the EA for testing of tap water and
assent for themselves (32 hours). their children, 3–11 years old (66 indoor dust samples; therefore, the
Exposure Assessment Questionnaires hours); and 15 minutes for 191 children, desired number of households is 15 per
for Biological and Environmental 12–17 years old, who respond for EA, or 76 per year (152 * 10/100 * 5).
Testing for Adults, Parents, or Children: themselves (48 hours). The time associated with consenting to
ATSDR/NCEH will administer an Household Recruitment Script for the environmental sampling is 10
exposure questionnaire to all consented Environmental Sampling: The minutes, resulting in a burden of 13
respondents that includes questions households providing environmental hours annually for five EAs.
associated with potential exposure to samples (tap water and indoor dust) will
PFAS both inside and outside the home be a random 10 percent subset of Environmental Sample Collection
(e.g., work or school). The adult households that report using tap water Form: ATSDR will collect samples from
questionnaire also includes several for drinking water. Assuming a 65 approximately 15 households per EA or
questions associated with water use and percent response rate, ATSDR/NCEH 76 households annually (152*10/100*5)
flooring type while the child will administer a five-minute and fill out a sample collection form.
questionnaire includes questions recruitment script to 23 heads-of The average time burden is estimated as
regarding playing in soil; these households who are eligible to take part 15 minutes per response for the sample
questions are intended to evaluate in each EA (152/10 * 100/65). This will collection forms (19 hours annually).
potential exposure and to support the result in annual recruitment from 117 ATSDR estimates the total annualized
environmental testing. The time heads-of-households and 10 hours for time burden is 1,390 hours.
associated with administering the five EAs. Participation is voluntary, and there are
questionnaire and completing the Consent for Environmental Testing: no costs to respondents other than their
biological sampling is approximately 30 ATSDR/NCEH will consent a 10 percent time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
EA Community Members ....... Community Event Evaluation Survey ..................................... 815 1 5/60
EA Adults ............................... Household Eligibility Screener ................................................ 1,170 1 5/60
Consent ................................................................................... 1,440 1 10/60
Exposure Questionnaire (Adult)for Biological and Environ- 1,440 1 30/60
mental Testing.
EA Parents ............................. Parental Permission ................................................................ 455 1 10/60
Exposure Questionnaire (Child)for Biological Testing (Parent 264 1 15/60
Proxy).
EA Children ............................ Assent ..................................................................................... 191 1 10/60
Exposure Questionnaire (Child)for Biological Testing (Child 191 1 15/60
completed).
EA Heads-of-Households ....... Household Recruitment Script for Environmental Sampling .. 117 1 5/60
Environmental Sampling Consent Form ................................. 76 1 10/60
Environmental Sample Collection Form ................................. 76 1 15/60
Jeffrey M. Zirger, ACTION: Notice with comment period. DATES:CDC must receive written
Acting Team Lead, Information Collection comments on or before January 28,
Review Office, Office of Scientific Integrity, SUMMARY: The Centers for Disease 2019.
Office of Science, Centers for Disease Control Control and Prevention (CDC), as part of
and Prevention. ADDRESSES: You may submit comments,
its continuing effort to reduce public identified by Docket No. CDC–2018–
[FR Doc. 2018–25626 Filed 11–26–18; 8:45 am]
burden and maximize the utility of 0104 by any of the following methods:
BILLING CODE 4163–18–P
government information, invites the • Federal eRulemaking Portal:
general public and other Federal Regulations.gov. Follow the instructions
DEPARTMENT OF HEALTH AND agencies the opportunity to comment on for submitting comments.
HUMAN SERVICES a proposed and/or continuing • Mail: Jeffrey M. Zirger, Information
information collection, as required by Collection Review Office, Centers for
Centers for Disease Control and the Paperwork Reduction Act of 1995. Disease Control and Prevention, 1600
Prevention This notice invites comment on a Clifton Road NE, MS–D74, Atlanta,
proposed information collection project Georgia 30329.
[60Day–19–19BN; Docket No. CDC–2018– titled ‘‘Emergency Cruise Ship Outbreak Instructions: All submissions received
0104] must include the agency name and
Investigations (CSOIs)’’. The purpose of
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this study is to allow the CDC Vessel Docket Number. CDC will post, without
Proposed Data Collection Submitted
Sanitation Program (VSP) to prevent the change, all relevant comments to
for Public Comment and
introduction, transmission, or spread of Regulations.gov.
Recommendations
acute gastroenteritis (AGE) via cruise Please note: Submit all comments
AGENCY: Centers for Disease Control and ships entering the United States from through the Federal eRulemaking portal
Prevention (CDC), Department of Health foreign countries. (regulations.gov) or by U.S. mail to the
and Human Services (HHS). address listed above.
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![Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices 60869
FOR FURTHER INFORMATION CONTACT: To Background and Brief Description following types of information from
request more information on the Established in 1975 as a cooperative both the affected and (seemingly)
proposed project or to obtain a copy of activity with the cruise ship industry, unaffected populations:
the information collection plan and the Centers for Disease Control and • Demographic information,
instruments, contact Jeffrey M. Zirger, Prevention (CDC) Vessel Sanitation • Pre-embarkation travel information,
Information Collection Review Office, Program (VSP) develops and • Symptoms, including type, onset,
Centers for Disease Control and implements comprehensive sanitation duration,
Prevention, 1600 Clifton Road NE, MS– programs to minimize the risk of • Contact with people who were sick
D74, Atlanta, Georgia 30329; phone: or their body fluids,
gastrointestinal diseases, by
404–639–7570; Email: omb@cdc.gov.
coordinating and conducting • Participation in ship and shore
SUPPLEMENTARY INFORMATION: Under the operational inspections, ongoing activities,
Paperwork Reduction Act of 1995 (PRA) surveillance of gastrointestinal illness, • Locations of eating and drinking,
(44 U.S.C. 3501–3520), Federal agencies and outbreak investigations on vessels. and
must obtain approval from the Office of Under the authority of the Public • Foods and beverages consumed
Management and Budget (OMB) for each Health Service Act (42 U.S.C. Sections both on the ship and on shore.
collection of information they conduct 264 and 269), the VSP is requesting a
or sponsor. In addition, the PRA also Rapid and flexible data collection is
three-year approval for a new generic imperative given the mobile
requires Federal agencies to provide a clearance information collection request
60-day notice in the Federal Register environment, the remaining duration of
(ICR). This ICR will provide the quick the voyage left for investigation, and the
concerning each proposed collection of turn-around necessary to conduct
information, including each new loss to follow-up if delays allow
emergency cruise ship outbreak passengers to disembark and leave the
proposed collection, each proposed investigations (CSOIs) in response to
extension of existing collection of ship, including those returning to
acute gastroenteritis (AGE) outbreaks. locations outside of the U.S.
information, and each reinstatement of CSOIs are used to determine the
previously approved information This new generic clearance will cover
causative agents and their sources, investigations that meet all of the
collection before submitting the modes of transmission, or risk factors.
collection to the OMB for approval. To following criteria:
The VSP’s jurisdiction includes • The investigation is urgent in
comply with this requirement, we are passenger vessels carrying 13 or more
publishing this notice of a proposed nature (i.e., timely data are needed to
people sailing from foreign ports and inform rapid public health action to
data collection as described below. within 15 days of arriving at a U.S. port.
The OMB is particularly interested in prevent or reduce morbidity or
VSP uses its syndromic surveillance mortality).
comments that will help: system called the Maritime Illness and
1. Evaluate whether the proposed • The investigation is characterized
Death Reporting System (MIDRS)
collection of information is necessary by undetermined agents, undetermined
(approved under ‘‘Foreign Quarantine
for the proper performance of the sources, undetermined modes of
Regulations’’ [OMB Control No. 0920–
functions of the agency, including transmission, or undetermined risk
0134, expiration date 05/31/2019]) to
whether the information will have factors.
collect aggregate data about the number
practical utility;
of people onboard ships in VSP’s • One or more CDC staff (including
2. Evaluate the accuracy of the trainees and fellows) will be deployed
agency’s estimate of the burden of the jurisdiction who are experiencing AGE
symptoms. When the levels of illness to the field.
proposed collection of information,
meet VSP’s alert threshold (i.e., at least • Most CSOIs involve two to five days
including the validity of the of data collection; data collection is
methodology and assumptions used; 2% in either the passenger or crew
populations), a special report is made to completed in 30 days or less.
3. Enhance the quality, utility, and This new generic clearance excludes
clarity of the information to be VSP via MIDRS and remote
environmental health and each of the following:
collected; and • Investigations related to non-urgent
4. Minimize the burden of the epidemiologic assistance is provided.
collection of information on those who VSP considers an outbreak to be ≥3% of outbreaks or events.
are to respond, including through the reportable AGE cases in either guest or • Investigations conducted for the
use of appropriate automated, crew populations. When assistance is primary purpose of program evaluation,
electronic, mechanical, or other needed due to AGE outbreaks on cruise surveillance, needs assessment, or
technological collection techniques or ships, this often requires VSP to deploy research (e.g., to contribute to
other forms of information technology, a response team to meet the ship in port generalizable knowledge).
e.g., permitting electronic submissions within 24 hours of reaching the • Investigations with data collection
of responses. outbreak threshold, and in some cases expected for greater than 30 days.
5. Assess information collection costs. deploying the response team to board The VSP estimates 10 CSOIs annually
the ship before its U.S. arrival and sail in response to cruise ship AGE
Proposed Project back to the U.S. port of disembarkation outbreaks. The estimated number of
Emergency Cruise Ship Outbreak to conduct a more detailed and respondents is 2,500 per CSOI, for a
Investigations (COIs)—Existing comprehensive epidemiologic and total of 25,000 respondents per year.
Collection in Use without an OMB environmental health evaluation of the The average time burden is 15 minutes
Control Number—National Center for outbreak. for each respondent. Therefore, the total
amozie on DSK3GDR082PROD with NOTICES1
Environmental Health (NCEH), Centers Causative agent, sources of exposure, estimated annual burden in hours is
for Disease Control and Prevention modes of transmission, and risk factors 6,250. There is no cost to respondents
(CDC). can be ascertained by gathering the other than their time.
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![60870 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
Cruise Ship Passengers or Crew ................................... Questionnaire ...... 24,750 1 15/60 6,188
Cruise Ship Passengers or Crew ................................... Interview .............. 250 1 15/60 62
Total ........................................................................ ............................. ........................ ........................ ........................ 6,250
Jeffrey M. Zirger, (d) Minimize the burden of the These practices and procedures ensure
Acting Lead, Information Collection Review collection of information on those who protection against the introduction and
Office, Office of Scientific Integrity, Office are to respond, including, through the spread of communicable diseases into
of Science, Centers for Disease Control and use of appropriate automated, and within the United States with a
Prevention. electronic, mechanical, or other minimum of recordkeeping and
[FR Doc. 2018–25752 Filed 11–26–18; 8:45 am] technological collection techniques or reporting procedures, as well as a
BILLING CODE 4163–18–P other forms of information technology, minimum of interference with trade and
e.g., permitting electronic submission of travel.
responses; and U.S. Quarantine Stations are located
DEPARTMENT OF HEALTH AND (e) Assess information collection
HUMAN SERVICES at 20 ports of entry and land-border
costs.
crossings where international travelers
To request additional information on
Centers for Disease Control and arrive. The jurisdiction of each station
the proposed project or to obtain a copy
Prevention of the information collection plan and includes air, maritime, and/or land-
instruments, call (404) 639–7570 or border ports of entry. Quarantine
send an email to omb@cdc.gov. Direct Station staff work in partnership with
[30Day–19–0134]
written comments and/or suggestions international, federal, state, and local
Agency Forms Undergoing Paperwork regarding the items contained in this agencies and organizations to fulfill
Reduction Act Review notice to the Attention: CDC Desk their mission to reduce morbidity and
Officer, Office of Management and mortality among globally mobile
In accordance with the Paperwork populations. This work is performed to
Budget, 725 17th Street NW,
Reduction Act of 1995, the Centers for prevent the introduction, transmission,
Washington, DC 20503 or by fax to (202)
Disease Control and Prevention (CDC) and spread of communicable diseases
395–5806. Provide written comments
has submitted the information from foreign countries into the United
within 30 days of notice publication.
collection request titled Foreign States or from one State or possession to
Quarantine Regulations (42 CFR 71) to Proposed Project another State or possession. When an
the Office of Management and Budget Foreign Quarantine Regulations (42 illness suggestive of a communicable
(OMB) for review and approval. CDC CFR 71) (OMB Control No. 0920–0134) disease is reported by conveyance
previously published a ‘‘Proposed Data (Exp 5/31/2019)—National Center for operators or port partners (e.g. Customs
Collection Submitted for Public Emerging and Zoonotic Infectious and Border Protection), Quarantine
Comment and Recommendations’’ Diseases (NCEZID), Centers for Disease Officers respond to carry out an onsite
notice on September 7, 2018 to obtain Control and Prevention (CDC). public health assessment and collect
comments from the public and affected data from the individual. This response
agencies. CDC did not receive comments Background and Brief Description may occur jointly with port partners.
related to the previous notice. This Section 361 of the Public Health The collection of comprehensive,
notice serves to allow an additional 30 Service Act (PHSA) (42 U.S.C. 264) pertinent public health information
days for public and affected agency authorizes the Secretary of Health and during these responses enables
comments. Human Services to make and enforce Quarantine Officers to make an accurate
CDC will accept all comments for this regulations necessary to prevent the public health assessment and identify
proposed information collection project. introduction, transmission or spread of appropriate next steps. For this reason,
The Office of Management and Budget communicable diseases from foreign quarantine station staff need to
is particularly interested in comments countries into the United States. Statute systematically interview ill travelers
that: and the existing regulations governing and collect relevant health and
(a) Evaluate whether the proposed foreign quarantine activities (42 CFR 71) epidemiologic information.
collection of information is necessary authorize quarantine officers and other CDC is making a number of changes
for the proper performance of the personnel to inspect and undertake and adjustments to this information
functions of the agency, including necessary control measures with respect collection. The changes are as follows:
whether the information will have to conveyances, persons, and shipments
practical utility; of animals and etiologic agents in order • CDC is merging this information
(b) Evaluate the accuracy of the to protect the public’s health. Other collection with another, 0920–0821
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agencies estimate of the burden of the inspection agencies, such as Customs Illness Response Forms: Airline,
proposed collection of information, and Border Protection (CBP), assist Maritime, and Land/Border Crossing.
including the validity of the quarantine officers in public health • CDC is disaggregating the
methodology and assumptions used; screening of persons, pets, and other information collection 42 CFR 71.21(a)
(c) Enhance the quality, utility, and importations of public health report of illness or death from ships so
clarity of the information to be importance and make referrals to that the influenza like illness (ILI)
collected; quarantine station staff when indicated. report, which is voluntary, is separate
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Document Created: 2018-11-27 01:24:31
Document Modified: 2018-11-27 01:24:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before January 28, 2019. | |
| 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] | |
| FR Citation | 83 FR 60868 |
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