83_FR_27715 83 FR 27601 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 27601 - 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 114 (June 13, 2018)

Page Range27601-27602
FR Document2018-12637

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 the National Notifiable Diseases Surveillance System (NNDSS). The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under standard surveillance.

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018) 
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27601-27602]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0728; Docket No. CDC-2018-0047]


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.

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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 the National Notifiable Diseases 
Surveillance System (NNDSS). The NNDSS is the nation's public health 
surveillance system that monitors the occurrence and spread of diseases 
and conditions that are nationally notifiable or under standard 
surveillance.

DATES: CDC must receive written comments on or before August 13, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0047 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 Leroy A. Richardson, 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

    National Notifiable Diseases Surveillance System--Revision--Center 
for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The Public Health Services Act (42 U.S.C. 241) authorizes CDC to 
disseminate nationally notifiable condition information. The National 
Notifiable Diseases Surveillance System (NNDSS) is based on data 
collected at the state, territorial and local levels as a result of 
legislation and regulations in those jurisdictions that require health 
care providers, medical laboratories, and other entities to submit 
health-related data on reportable conditions to public health 
departments. These reportable conditions, which include infectious and 
non-infectious diseases, vary by jurisdiction depending upon each 
jurisdiction's health priorities and needs. Each year, the Council of 
State and Territorial Disease Epidemiologists (CSTE), supported by CDC, 
determines which reportable conditions should be designated nationally 
notifiable or under standardized surveillance.
    CDC requests a three-year approval for a Revision for the NNDSS, 
OMB Control No. 0920-0728, Expiration Date 02/28/2021. This Revision 
includes requests for approval to: (1) Receive case notification data 
for Salmonella enterica serotype Paratyphi (S. Paratyphi) A, B, or C 
Infections should they become nationally notifiable or be placed under 
standardized surveillance; (2) receive case notification data for 
Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae (CP-
CRE) which is now nationally notifiable; (3) receive case notification 
data for Candida auris (C. auris) which is now under standardized 
surveillance; and (4) receive disease-specific data elements for CP-
CRE.
    The NNDSS currently facilitates the submission and aggregation of 
case notification data voluntarily submitted to CDC from 60 
jurisdictions: Public health departments in every U.S. state,

[[Page 27602]]

New York City, Washington DC, 5 U.S. territories (American Samoa, the 
Commonwealth of Northern Mariana Islands, Guam, Puerto Rico, and the 
U.S. Virgin Islands), and 3 freely associated states (Federated States 
of Micronesia, the Republic of the Marshall Islands, and the Republic 
of Palau). This information is shared across jurisdictional boundaries 
and both surveillance and prevention and control activities are 
coordinated at regional and national levels.
    Approximately 90% of case notifications are encrypted and submitted 
to NNDSS electronically from already existing databases by automated 
electronic messages. When automated transmission is not possible, case 
notifications are faxed, emailed, uploaded to a secure network or 
entered into a secure website. All case notifications that are faxed, 
emailed, and uploaded are done so in the form of an aggregate weekly or 
annual report, not individual cases. These different mechanisms used to 
send case notifications to CDC vary by the jurisdiction and the disease 
or condition. Private personally identifiable information (PII) is 
collected from automated electronic messages and information can be 
retrieved by PII. In addition, some combinations of submitted data 
elements could potentially be used to identify individuals. Private 
information is not be disclosed unless otherwise compelled by law. All 
data are treated in a secure manner consistent with the technical, 
administrative, and operational controls required by the Federal 
Information Security Management Act of 2002 (FISMA) and the 2010 
National Institute of Standards and Technology (NIST) Recommended 
Security Controls for Federal Information Systems and Organizations. 
Weekly tables of nationally notifiable diseases are available through 
CDC WONDER and data.cdc.gov. Annual summaries of finalized nationally 
notifiable disease data are published on CDC WONDER and data.cdc.gov 
and disease-specific data are published by individual CDC programs.
    The burden estimates include the number of hours that the public 
health department uses to process and send case notification data from 
their jurisdiction to CDC. Specifically, the burden estimates include 
separate burden hours incurred for automated and non-automated 
transmissions, separate weekly burden hours incurred for modernizing 
surveillance systems as part of NNDSS Modernization Initiative (NMI) 
implementation, separate burden hours incurred for annual data 
reconciliation and submission, and separate one-time burden hours 
incurred for the addition of new diseases and data elements. The burden 
estimates also include the one-time burden for reporting jurisdictions 
for the addition of case notification data for CP-CRE and C. auris and 
disease-specific data elements for CP-CRE. The estimated annual burden 
for the 233 respondents is 18,619 hours. The cost of the information 
collection is $787,846. The total burden hours increased from 18,529 to 
18,619 since the last revision because of the addition of diseases and 
disease-specific data elements.

                                        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)
----------------------------------------------------------------------------------------------------------------
States........................  Weekly                        50              52           20/60             867
                                 (Automated).
States........................  Weekly (Non-                  10              52               2           1,040
                                 Automated).
States........................  Weekly (NMI                   50              52               4          10,400
                                 Implementation).
States........................  Annual..........              50               1              75           3,750
States........................  One-time                      50               1              10             485
                                 Addition of
                                 Diseases and
                                 Data Elements.
Territories...................  Weekly                         1              52           20/60              17
                                 (Automated).
Territories...................  Weekly,                        5              56           20/60              93
                                 Quarterly (Non-
                                 Automated).
Territories...................  Weekly (NMI                    5              52               4           1,040
                                 Implementation).
Territories...................  Annual..........               5               1               5              25
Territories...................  One-time                       1               1           10/60               1
                                 Addition of
                                 Diseases and
                                 Data Elements.
Freely Associated States......  Weekly,                        3              56           20/60              56
                                 Quarterly (Non-
                                 Automated).
Freely Associated States......  Annual..........               3               1               5              15
----------------------------------------------------------------------------------------------------------------


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. 2018-12637 Filed 6-12-18; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27601 Respondents/Affected Entities: Private conditions that are nationally notifiable 3. Enhance the quality, utility, and sector. or under standard surveillance. clarity of the information to be Respondent’s Obligation to Respond: DATES: CDC must receive written collected; and Mandatory per 48 CFR 1552.211. comments on or before August 13, 2018. 4. Minimize the burden of the Estimated Number of Respondents: ADDRESSES: You may submit comments, collection of information on those who 337 (total). identified by Docket No. CDC–2018– are to respond, including through the Frequency of Response: Monthly. 0047 by any of the following methods: use of appropriate automated, Total Estimated Burden: 97,056 hours • Federal eRulemaking Portal: electronic, mechanical, or other (per year). Burden is defined at 5 CFR Regulations.gov. Follow the instructions technological collection techniques or 1320.03(b). for submitting comments. other forms of information technology, Total Estimated Cost: $9,074,736 (per • Mail: Jeffrey M. Zirger, Information e.g., permitting electronic submissions year), includes $0 annualized capital or Collection Review Office, Centers for of responses. operation & maintenance costs. Disease Control and Prevention, 1600 5. Assess information collection costs. Changes in Estimates: There is an Clifton Road NE, MS–D74, Atlanta, Proposed Project increase of 19,650 hours Georgia 30329. (97,056¥77,406) in the total estimated National Notifiable Diseases Instructions: All submissions received respondent burden compared with the Surveillance System—Revision—Center must include the agency name and ICR currently approved by OMB for Surveillance, Epidemiology and Docket Number. CDC will post, without because there are approximately 337 Laboratory Services (CSELS), Centers for change, all relevant comments to contracts and orders requiring response Disease Control and Prevention (CDC). Regulations.gov. in 2018 instead of only 266 in 2014. Please note: Submit all comments Background and Brief Description This figure has increased to 337 due in through the Federal eRulemaking portal The Public Health Services Act (42 part to shorter-value and shorter-length (regulations.gov) or by U.S. mail to the U.S.C. 241) authorizes CDC to contracts being awarded due to budget address listed above. disseminate nationally notifiable uncertainty; e.g., continuing funding FOR FURTHER INFORMATION CONTACT: To condition information. The National resolutions, sequestration budget cuts. request more information on the Notifiable Diseases Surveillance System Dated: May 24, 2018. proposed project or to obtain a copy of (NNDSS) is based on data collected at Pamela D. Legare, the information collection plan and the state, territorial and local levels as Deputy Director, Office of Acquisition instruments, contact Leroy A. a result of legislation and regulations in Management. Richardson, Information Collection those jurisdictions that require health [FR Doc. 2018–12712 Filed 6–12–18; 8:45 am] Review Office, Centers for Disease care providers, medical laboratories, BILLING CODE 6560–50–P Control and Prevention, 1600 Clifton and other entities to submit health- Road NE, MS–D74, Atlanta, Georgia related data on reportable conditions to 30329; phone: 404–639–7570; Email: public health departments. These omb@cdc.gov. reportable conditions, which include DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: Under the infectious and non-infectious diseases, Paperwork Reduction Act of 1995 (PRA) vary by jurisdiction depending upon Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies each jurisdiction’s health priorities and Prevention must obtain approval from the Office of needs. Each year, the Council of State Management and Budget (OMB) for each and Territorial Disease Epidemiologists [60Day–18–0728; Docket No. CDC–2018– collection of information they conduct (CSTE), supported by CDC, determines 0047] or sponsor. In addition, the PRA also which reportable conditions should be Proposed Data Collection Submitted requires Federal agencies to provide a designated nationally notifiable or for Public Comment and 60-day notice in the Federal Register under standardized surveillance. Recommendations concerning each proposed collection of CDC requests a three-year approval for information, including each new a Revision for the NNDSS, OMB Control AGENCY: Centers for Disease Control and proposed collection, each proposed No. 0920–0728, Expiration Date 02/28/ Prevention (CDC), Department of Health extension of existing collection of 2021. This Revision includes requests and Human Services (HHS). information, and each reinstatement of for approval to: (1) Receive case ACTION: Notice with comment period. previously approved information notification data for Salmonella enterica collection before submitting the serotype Paratyphi (S. Paratyphi) A, B, SUMMARY: The Centers for Disease collection to the OMB for approval. To or C Infections should they become Control and Prevention (CDC), as part of comply with this requirement, we are nationally notifiable or be placed under its continuing effort to reduce public publishing this notice of a proposed standardized surveillance; (2) receive burden and maximize the utility of data collection as described below. case notification data for government information, invites the The OMB is particularly interested in Carbapenemase-Producing Carbapenem- general public and other Federal comments that will help: Resistant Enterobacteriaceae (CP–CRE) agencies the opportunity to comment on 1. Evaluate whether the proposed which is now nationally notifiable; (3) a proposed and/or continuing collection of information is necessary receive case notification data for information collection, as required by for the proper performance of the Candida auris (C. auris) which is now the Paperwork Reduction Act of 1995. functions of the agency, including under standardized surveillance; and (4) amozie on DSK3GDR082PROD with NOTICES1 This notice invites comment on a whether the information will have receive disease-specific data elements proposed information collection project practical utility; for CP–CRE. titled the National Notifiable Diseases 2. Evaluate the accuracy of the The NNDSS currently facilitates the Surveillance System (NNDSS). The agency’s estimate of the burden of the submission and aggregation of case NNDSS is the nation’s public health proposed collection of information, notification data voluntarily submitted surveillance system that monitors the including the validity of the to CDC from 60 jurisdictions: Public occurrence and spread of diseases and methodology and assumptions used; health departments in every U.S. state, VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1

27602 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices New York City, Washington DC, 5 U.S. condition. Private personally department uses to process and send territories (American Samoa, the identifiable information (PII) is case notification data from their Commonwealth of Northern Mariana collected from automated electronic jurisdiction to CDC. Specifically, the Islands, Guam, Puerto Rico, and the U.S. messages and information can be burden estimates include separate Virgin Islands), and 3 freely associated retrieved by PII. In addition, some burden hours incurred for automated states (Federated States of Micronesia, combinations of submitted data and non-automated transmissions, the Republic of the Marshall Islands, elements could potentially be used to separate weekly burden hours incurred and the Republic of Palau). This identify individuals. Private information for modernizing surveillance systems as information is shared across is not be disclosed unless otherwise part of NNDSS Modernization Initiative jurisdictional boundaries and both compelled by law. All data are treated (NMI) implementation, separate burden surveillance and prevention and control in a secure manner consistent with the hours incurred for annual data activities are coordinated at regional technical, administrative, and and national levels. operational controls required by the reconciliation and submission, and Approximately 90% of case Federal Information Security separate one-time burden hours notifications are encrypted and Management Act of 2002 (FISMA) and incurred for the addition of new submitted to NNDSS electronically from the 2010 National Institute of Standards diseases and data elements. The burden already existing databases by automated and Technology (NIST) Recommended estimates also include the one-time electronic messages. When automated Security Controls for Federal burden for reporting jurisdictions for the transmission is not possible, case Information Systems and Organizations. addition of case notification data for notifications are faxed, emailed, Weekly tables of nationally notifiable CP–CRE and C. auris and disease- uploaded to a secure network or entered diseases are available through CDC specific data elements for CP–CRE. The into a secure website. All case WONDER and data.cdc.gov. Annual estimated annual burden for the 233 notifications that are faxed, emailed, summaries of finalized nationally respondents is 18,619 hours. The cost of and uploaded are done so in the form notifiable disease data are published on the information collection is $787,846. of an aggregate weekly or annual report, CDC WONDER and data.cdc.gov and The total burden hours increased from not individual cases. These different disease-specific data are published by 18,529 to 18,619 since the last revision mechanisms used to send case individual CDC programs. because of the addition of diseases and notifications to CDC vary by the The burden estimates include the disease-specific data elements. jurisdiction and the disease or number of hours that the public health ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Total Number of burden per Type of respondents Form name responses per burden respondents response respondent (in hours) (in hours) States ................................................ Weekly (Automated) ......................... 50 52 20/60 867 States ................................................ Weekly (Non-Automated) ................. 10 52 2 1,040 States ................................................ Weekly (NMI Implementation) .......... 50 52 4 10,400 States ................................................ Annual .............................................. 50 1 75 3,750 States ................................................ One-time Addition of Diseases and 50 1 10 485 Data Elements. Territories .......................................... Weekly (Automated) ......................... 1 52 20/60 17 Territories .......................................... Weekly, Quarterly (Non-Automated) 5 56 20/60 93 Territories .......................................... Weekly (NMI Implementation) .......... 5 52 4 1,040 Territories .......................................... Annual .............................................. 5 1 5 25 Territories .......................................... One-time Addition of Diseases and 1 1 10/60 1 Data Elements. Freely Associated States .................. Weekly, Quarterly (Non-Automated) 3 56 20/60 56 Freely Associated States .................. Annual .............................................. 3 1 5 15 Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND announcing the availability of a Acting Chief, Information Collection Review HUMAN SERVICES guidance for industry entitled ‘‘Medical Office, Office of Scientific Integrity, Office Product Communications That Are of the Associate Director for Science, Office Food and Drug Administration Consistent With the FDA-Required of the Director, Centers for Disease Control Labeling—Questions and Answers.’’ [Docket No. FDA–2016–D–2285] and Prevention. This guidance provides information for [FR Doc. 2018–12637 Filed 6–12–18; 8:45 am] Medical Product Communications That manufacturers, packers, and distributors BILLING CODE 4163–18–P Are Consistent With the Food and and their representatives (collectively Drug Administration-Required ‘‘firms’’) of drugs and medical devices Labeling—Questions and Answers; for humans, including those that are amozie on DSK3GDR082PROD with NOTICES1 Guidance for Industry; Availability licensed as biological products, and AGENCY: Food and Drug Administration, animal drugs (collectively ‘‘medical HHS. products’’), about how FDA evaluates their medical product communications ACTION: Notice of availability. that present information that is not SUMMARY: The Food and Drug contained in the FDA-required labeling Administration (FDA or Agency) is for the product but that may be VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1


Document Created: 2018-06-12 23:59:17
Document Modified: 2018-06-12 23:59:17
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 August 13, 2018.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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 27601 
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