Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27601 

Respondents/Affected Entities: Private 

sector. 

Respondent’s Obligation to Respond: 

Mandatory per 48 CFR 1552.211. 

Estimated Number of Respondents: 

337 (total). 

Frequency of Response: Monthly. 

Total Estimated Burden: 97,056 hours 

(per year). Burden is defined at 5 CFR 

1320.03(b). 

Total Estimated Cost: $9,074,736 (per 

year), includes $0 annualized capital or 

operation & maintenance costs. 

Changes in Estimates: There is an 

increase of 19,650 hours 

(97,056¥77,406) in the total estimated 

respondent burden compared with the 

ICR currently approved by OMB 

because there are approximately 337 

contracts and orders requiring response 

in 2018 instead of only 266 in 2014. 

This figure has increased to 337 due in 

part to shorter-value and shorter-length 

contracts being awarded due to budget 

uncertainty; e.g., continuing funding 

resolutions, sequestration budget cuts. 

Dated: May 24, 2018. 

Pamela D. Legare, 

Deputy Director, Office of Acquisition 

Management. 

[FR Doc. 2018–12712 Filed 6–12–18; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

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 

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 healthrelated 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 CarbapenemResistant 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, 


amozie on DSK3GDR082PROD with NOTICES1
27602 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

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 diseasespecific 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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(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 

Data Elements.

50 1 10 485 

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 

Data Elements.

1 1 10/60 1 

Freely Associated States .................. Weekly, Quarterly (Non-Automated) 3 56 20/60 56 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2285] 

Medical Product Communications That 

Are Consistent With the Food and 

Drug Administration-Required 

Labeling—Questions and Answers; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry entitled ‘‘Medical 

Product Communications That Are 

Consistent With the FDA-Required 

Labeling—Questions and Answers.’’ 

This guidance provides information for 

manufacturers, packers, and distributors 

and their representatives (collectively 

‘‘firms’’) of drugs and medical devices 

for humans, including those that are 

licensed as biological products, and 

animal drugs (collectively ‘‘medical 

products’’), about how FDA evaluates 

their medical product communications 

that present information that is not 

contained in the FDA-required labeling 

for the product but that may be 


amozie on DSK3GDR082PROD with NOTICES1