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 


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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27603 

consistent with the FDA-required 

labeling for the product. The Agency is 

issuing this guidance to explain FDA’s 

current thinking on commonly asked 

questions regarding such 

communications to provide clarity for 

firms. FDA is also announcing that a 

proposed collection of information has 

been submitted to the Office of 

Management and Budget (OMB) for 

review and clearance under the 

Paperwork Reduction Act of 1995. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 13, 2018. Submit 

written comments on the collection of 

information by July 13, 2018. 

ADDRESSES: To ensure comments on the 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Recommended Content of Medical 

Product Communications That Are 

Consistent With the FDA-Required 

Labeling—Questions and Answers; 

Guidance for Industry.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

You may submit either electronic or 

written comments on Agency guidances 

at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–2285 for ‘‘Medical Product 

Communications That Are Consistent 

With the FDA-Required Labeling— 

Questions and Answers; Guidance for 

Industry; Availability.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Office of Communication, Education 

and Radiation Programs, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4613, 

Silver Spring, MD 20993–0002; or to 

Policy and Regulations Staff (HFV–6), 

Center for Veterinary Medicine, Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Kristin Davis, 

Office of Policy, Office of the 

Commissioner, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 4252, Silver Spring, 

MD 20993–0002, 301–796–0418; or 

Elizabeth Pepinsky, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3248, 

Silver Spring, MD 20993–0002, 301– 

796–1200; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911; or Ana Loloei Marsal, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5452, Silver Spring, MD 20993– 

0002, 301–796–8774; or Thomas 

Moskal, Center for Veterinary Medicine, 

Food and Drug Administration, 7519 


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27604 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

1As used in the guidance, the term FDA-required 

labeling includes the labeling reviewed and 

approved by FDA as part of the medical product 

marketing application review process. For products 

not subject to premarket approval, but instead 

subject to premarket notification (510(k)) 

requirements or exempt from premarket review, the 

term FDA-required labeling includes the labeling 

that provides adequate directions for use and other 

information required to appear on the label or in 

labeling. 

Standish Pl. (HFV–216), Rockville, MD 

20855, 240–402–6251. 

Regarding the information collection: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 11601 Landsdown 

St., 10A–12M, North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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 

firms about how FDA evaluates their 

medical product communications (that 

fall within the scope of FDA’s regulatory 

authority) that present information that 

is not contained in the FDA-required 

labeling 1 for the product but that may 

be consistent with the FDA-required 

labeling for the product. 

FDA determines whether a medical 

product is safe and effective for use 

under the conditions prescribed, 

recommended, or suggested in the 

proposed labeling submitted with the 

product’s marketing application or 

submission (and for devices, also during 

the classification process). In making 

this determination, FDA evaluates 

whether the conditions of use in the 

proposed labeling are supported by the 

required levels and types of evidence of 

safety and effectiveness and whether the 

benefits of using the product under 

those specific conditions of use 

outweigh the risks of the product. After 

FDA approves, clears, or licenses a 

medical product, the FDA-required 

labeling sets forth the conditions of use 

under which the product has been 

shown to meet the relevant standard for 

marketing, and it provides directions 

and information on how to use the 

product safely and effectively under 

those conditions. 

Medical product firms have told FDA 

that they are interested in 

communicating, including in their 

promotional materials, data and 

information about the approved/ 

cleared/licensed uses of their products 

that are not contained in their products’ 

FDA-required labeling. We are aware 

that firms have questions about how 

FDA determines whether such 

communications are consistent with the 

FDA-required labeling. 

The guidance describes FDA’s 

thinking when examining the 

consistency of a firm’s product 

communications with that product’s 

own FDA-required labeling. As 

explained in the guidance, if a firm 

communicates information that is not 

contained in its product’s FDA-required 

labeling but that is determined to be 

consistent with the FDA-required 

labeling, FDA does not intend to rely on 

that communication to establish a new 

intended use, different from the use(s) 

for which the product is legally 

marketed. Establishing a product’s 

intended uses is an element in 

establishing certain violations under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) and Public Health Service 

Act. However, firms’ communications 

about their products that are consistent 

with the products’ FDA-required 

labeling but that are false or misleading 

may subject a firm to enforcement 

action under the FD&C Act. Thus, the 

guidance not only describes FDA’s 

thinking on communications that are 

consistent with the FDA-required 

labeling, but also provides general 

recommendations intended to aid firms 

in complying with requirements in the 

FD&C Act and FDA’s implementing 

regulations for conveying information 

that is consistent with the FDA-required 

labeling in a truthful and nonmisleading way. The general 

recommendations provided in the 

guidance for conveying information in a 

truthful and non-misleading way are 

applicable only to drug and device 

labeling and prescription drug and 

restricted device advertising that are 

consistent with the FDA-required 

labeling. Communication of information 

that is not consistent with the FDArequired labeling is outside the scope of 

these recommendations. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on firms’ 

communications for their medical 

products that may be consistent with 

the FDA-required labeling. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

II. Paperwork Reduction Act of 1995 

In compliance with 44 U.S.C. 3507, 

FDA has submitted the following 

proposed collection for OMB review 

and clearance. 

Title: Recommended Content of 

Medical Product Communications That 

Are Consistent With the FDA-Required 

Labeling; OMB Control No. 0910—NEW. 

The guidance includes third-party 

disclosure recommendations regarding 

information that firms should include in 

communications that contain 

information not found in the FDArequired labeling for their medical 

products but that are consistent with the 

FDA-required labeling (as explained in 

the guidance) if they choose to publicly 

disseminate such materials. The 

guidance recommends that various 

aspects of study design and 

methodology for studies relied on in 

such communications be disclosed to 

provide material contextual information 

(e.g., type of study, study objectives, 

product dosage/use regimens, control(s) 

used, patient population studied), and 

that material limitations related to the 

study design, methodology, and results 

also be disclosed in a clear and 

prominent manner to help ensure that 

the communications are not false or 

misleading. Additionally, the guidance 

recommends that firms accurately 

characterize and contextualize the 

relevant information about the product, 

including by disclosing unfavorable or 

inconsistent findings. Finally, the 

guidance recommends that firms 

disclose material contextual information 

from the FDA-required labeling in these 

communications, such as data and 

information from studies in the FDArequired labeling that are relevant to the 

data or information presented in the 

communication (e.g., if a 

communication provides post-market 

information about the types and rates of 

occurrence of adverse events that have 

been observed in practice, the 

communication should also include 

information from the FDA-required 

labeling about the types and rates of 

occurrence of adverse reactions 

observed in clinical trials to provide 

context). 

In the Federal Register of January 19, 

2017 (82 FR 6575), we published a 

notice announcing the availability of the 

draft guidance document and included 

an analysis under the PRA of the 

information collection burden 

associated with our recommendations. 

No comments were received in response 

to the four information collection topics 

solicited in the notice. 

According to FDA data, 

approximately 162,000 FDA-regulated 


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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27605 

promotional materials are prepared by 

approximately 500 firms annually. Of 

these materials, we estimate 

approximately 5 percent contain unique 

presentations of information consistent 

with FDA-required labeling, as 

described in the guidance, submitted by 

approximately 64 percent (or 324) of the 

firms. Anticipating that the number of 

these FDA-regulated promotional 

materials will soon increase to 6 

percent, we estimate the 324 firms will 

prepare and disseminate annually 9,720 

FDA-regulated promotional materials 

that contain unique presentations of 

information that is consistent with the 

FDA-required labeling, as described in 

the guidance, and that therefore are 

recommended to include the proposed 

third party disclosures. Based on our 

experience reviewing FDA-regulated 

promotional materials for medical 

products, we estimate it will take 

respondents approximately 4 hours per 

unique presentation to prepare and 

incorporate the disclosures 

recommended in the guidance, if they 

choose to disseminate this information. 

We therefore estimate the burden of 

the information collection as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Type of information Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Recommended information to be included when firms 

choose to disseminate communications that are consistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA is issuing this final guidance 

subject to OMB approval of the 

collection of information. Before 

implementing the information 

collection provisions of the guidance, 

FDA will publish a notice in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

collection of information, including 

OMB control number(s) for newly 

approved collections. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm, 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, or 

https://www.regulations.gov. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12631 Filed 6–12–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1307] 

Drug and Device Manufacturer 

Communications With Payors, 

Formulary Committees, and Similar 

Entities—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 ‘‘Drug 

and Device Manufacturer 

Communications With Payors, 

Formulary Committees, and Similar 

Entities—Questions and Answers.’’ This 

guidance provides answers to common 

questions regarding the communication 

of health care economic information (d) 

about approved prescription drugs and 

approved or cleared medical devices by 

medical product manufacturers, 

packers, distributers, and their 

representatives (firms) to payors, 

formulary committees, or other similar 

entities with knowledge and expertise 

in the area of health care economic 

analysis (collectively referred to as 

payors). This guidance also provides 

answers to common questions about 

both firms’ dissemination of information 

to payors about medical products that 

are not yet approved or cleared for any 

use and firms’ dissemination of 

information to payors about unapproved 

uses of approved or cleared medical 

products. The Agency is issuing this 

guidance to explain FDA’s current 

thinking on frequently asked questions 

regarding these topics in order to 

provide clarity for firms and payors. 

FDA is also announcing that a proposed 

collection of information has been 

submitted to the Office of Management 

and Budget (OMB) for review and 

clearance under the Paperwork 

Reduction Act of 1995. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 13, 2018. Submit 

written comments on the collection of 

information by July 13, 2018. 

ADDRESSES: To ensure comments on the 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910-New and 

title ‘‘Recommendations for Drug and 

Device Manufacturer Communications 

With Payors, Formulary Committees, 

and Similar Entities.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

You may submit either electronic or 

written comments on Agency guidances 

at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 


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