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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27606 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

1The term ‘‘medical product’’ refers to both drugs 

and devices. 

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–1307 for ‘‘Drug and Device 

Manufacturer Communications With 

Payors, Formulary Committees, and 

Similar Entities—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; or 

to the Office of Communication, 

Education and Radiation Programs, 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed 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; Sheila 

Ryan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3320, Silver Spring, 

MD 20993–0002, 301–796–1200; 

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. 

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 and review staff 

entitled ‘‘Drug and Device Manufacturer 

Communications With Payors, 

Formulary Committees, and Similar 

Entities—Questions and Answers.’’ This 

guidance provides answers to common 

questions regarding firms’ 

communications of HCEI about their 

approved prescription drugs to payors. 

The guidance also provides answers to 

common questions regarding firms’ 

communications of HCEI about their 

approved or cleared medical devices to 

payors. In addition, the guidance 

addresses common questions relating to 

firms’ dissemination to payors of 

information about medical products 1

that are not yet approved or cleared for 

any use and about unapproved uses of 

approved/cleared medical products. For 

purposes of this guidance, the term 

‘‘payors’’ collectively refers to payors, 

formulary committees, or other similar 

entities with knowledge and expertise 

in the area of health care economic 

analysis that are responsible for making 

product selection or acquisition, 

formulary management, and/or coverage 

and reimbursement decisions on a 

population basis regarding drugs and/or 

devices on behalf of health care 

organizations, which may include 

entities such as integrated health care 

delivery networks, hospitals, and 

hospital systems. 

FDA is aware that payors seek a range 

of information on effectiveness, safety, 

and cost-effectiveness of approved/ 

cleared medical products, including 

information from firms, to help support 

their medical product selection, 

formulary management, and/or coverage 

and reimbursement decisions on a 


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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27607 

2As used in this guidance, the term ‘‘unapproved 

products’’ refers to drugs and devices that are not 

yet approved/cleared by FDA for any use (but 

which must be approved/cleared to be legally 

marketed), including products for which firms have 

submitted or plan to submit a new drug application, 

a biologics license application (including an 

application submitted under the 351(k) pathway), 

an abbreviated new drug application, a premarket 

approval application, a 510(k) submission, a De 

Novo submission under section 513(f)(2) of the 

FD&C Act (21 U.S.C. 360c(f)(2)), or a Humanitarian 

Device Exemption application. 

population basis. This information may 

differ from and may be in addition to 

the information FDA reviews in order to 

make drug and device approval or 

clearance decisions. Because coverage 

and reimbursement decisions by payors 

impact many patients, FDA believes it is 

critical that HCEI provided by firms to 

payors about their approved drugs and 

approved/cleared devices be truthful 

and non-misleading. 

With respect to HCEI regarding 

approved drugs, section 502(a) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 352(a)), as 

amended by section 114 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) and section 

3037 of the 21st Century Cures Act 

(Pub. L. 114–255), includes a provision 

regarding communication of HCEI about 

such drugs to payors. Section 502(a) of 

the FD&C Act indicates that HCEI 

provided to payors carrying out their 

responsibilities for the selection of 

drugs for coverage or reimbursement 

shall not be considered to be false or 

misleading if the HCEI relates to an 

FDA-approved indication for the drug, 

is based on competent and reliable 

scientific evidence, and includes, where 

applicable, a conspicuous and 

prominent statement describing any 

material differences between the health 

care economic information and the 

FDA-approved labeling for the drug. 

Section III.A of this guidance provides 

FDA’s current thinking on key concepts 

in section 502(a) of the FD&C Act and 

recommendations for how firms can 

communicate HCEI about approved 

drugs to payors in accordance with this 

section to help ensure that payors have 

information needed to make informed 

drug selection, formulary management, 

and/or coverage and reimbursement 

decisions and to help ensure that the 

information is not false or misleading. 

Section III.A also discusses how FDA’s 

requirements for submission of 

promotional materials apply to HCEI 

about approved drugs disseminated by 

firms to payors. If a firm disseminates 

HCEI about an approved drug in 

accordance with this guidance, FDA 

does not intend to consider such 

information false or misleading. In 

addition, FDA does not intend to use 

HCEI about approved drugs 

disseminated consistent with this 

guidance as evidence of a new intended 

use. 

When FDA published a notice 

announcing the availability of the draft 

guidance document in the Federal 

Register of January 19, 2017 (82 FR 

6568), the Agency specifically requested 

comments from interested parties on the 

extent to which the principles provided 

in section III.A of the draft guidance 

could be applicable to communications 

of HCEI about approved/cleared devices 

(82 FR 6568 at 6571). We also stated 

that, to the extent that interested parties 

believe that different considerations 

should apply to medical devices or that 

guidance is needed on additional issues 

with respect to medical device firms’ 

communications of HCEI about 

approved/cleared medical devices to 

payors, FDA is interested in input on 

those topics as well (Id.). FDA received 

23 comments on the draft guidance; 3 

comments expressed support for 

applying the recommendations in 

section III.A of the guidance to medical 

devices and no comments opposed 

applying these recommendations to 

medical devices. In response to this 

feedback, section III.B of the guidance 

provides FDA’s recommendations for 

how firms can communicate HCEI about 

approved or cleared devices to payors to 

help ensure that device firms’ 

communication of HCEI to payors is not 

false or misleading. These 

recommendations generally follow the 

recommendations in section III.A of the 

guidance. If a device firm disseminates 

HCEI about an approved or cleared 

device in accordance with this 

guidance, FDA does not intend to 

consider such information false or 

misleading. In addition, FDA does not 

intend to use HCEI about approved or 

cleared devices disseminated consistent 

with this guidance as evidence of a new 

intended use. 

FDA also recognizes that due in part 

to their need, in some situations, to plan 

for and make coverage and 

reimbursement decisions far in advance 

of the effective date of such decisions, 

payors are also interested in receiving 

information from drug and device firms 

about medical products that are not yet 

approved or cleared by FDA for any use, 

and about unapproved uses of 

approved/cleared medical products. 

Section III.C of the guidance discusses 

FDA’s thinking with respect to 

communication by firms to payors of 

information about unapproved 

products 2 and about unapproved uses 

of approved/cleared medical products. 

The draft guidance provided similar 

recommendations, but the relevant 

section only addressed communications 

related to unapproved products. As 

noted above, FDA received 23 

comments on the draft guidance; 17 of 

these comments requested that the 

Agency also provide recommendations 

for firms’ communications to payors of 

information about unapproved uses of 

approved/cleared medical products. No 

comments opposed providing 

recommendations on this topic. In 

response to these comments, section 

III.C of this guidance provides FDA’s 

recommendations on firms’ 

dissemination to payors of information 

about both unapproved products and 

about unapproved uses of approved/ 

cleared medical products. As with 

firms’ communications to payors of 

HCEI about approved prescription drugs 

and approved or cleared devices, it is 

essential that information provided by 

firms about their unapproved products 

and about unapproved uses of their 

approved/cleared medical products be 

truthful and non-misleading. Therefore, 

section III.C also lays out a series of 

recommendations to help achieve these 

goals. 

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 drug and device 

manufacturer communications with 

payors, formulary committees, and 

similar entities. 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: Recommendations for Drug and 

Device Manufacturer Communications 

With Payors, Formulary Committees, 

and Similar Entities; OMB Control No. 

0910—NEW. 

The information collection supports 

Agency guidance and includes ThirdParty Disclosure recommendations 

regarding information that firms should 

include in HCEI for prescription drugs 

if they choose to disseminate such 

materials (‘‘HCEI materials’’) to payors, 

in accordance with section 502(a) of the 

FD&C Act. Specifically, FDA 

recommends that various aspects of 

study design and methodology of an 

economic analysis (i.e., type of analysis, 

modeling technique, patient population, 

perspective/viewpoint, treatment 


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27608 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

comparator, time horizon, outcome 

measures, cost estimates, and 

assumptions); factors that limit 

generalizability of an economic analysis; 

limitations to an economic analysis; and 

sensitivity analyses, if applicable, be 

included in HCEI materials 

disseminated to payors to allow for 

informed decision-making. 

Furthermore, FDA recommends that 

firms include other information when 

disseminating HCEI materials, as 

applicable, to provide a balanced and 

complete presentation. Such 

information includes a statement of the 

FDA-approved indication of the drug 

and a copy of the most current FDAapproved labeling. Under section 502(a) 

of the FD&C Act, firms must also 

include a conspicuous and prominent 

statement to describe any material 

differences between the HCEI and the 

FDA-approved labeling. HCEI materials 

should also disclose whether certain 

studies or data sources were omitted 

from an economic analysis and how the 

omission of those studies or data 

sources may alter the conclusions 

presented in the analysis. Moreover, 

FDA recommends that HCEI materials 

disclose important risk information 

associated with the approved use of the 

drug, and pursuant to section 502(a) of 

the FD&C Act, must disclose any 

additional risk information related to 

assumptions that vary from the 

approved labeling. Finally, HCEI 

materials should disclose potential 

financial or affiliation biases to the 

extent reasonably known by firms at the 

time of dissemination. 

The guidance provides similar 

recommendations for HCEI materials 

disseminated to payors about approved 

or cleared devices. 

If firms choose to make 

communications to payors about 

unapproved products or unapproved 

uses of approved/cleared products, FDA 

recommends that firms include a clear 

statement with their communications 

that the product or use is not approved/ 

cleared and that the safety or 

effectiveness of the product or use has 

not been established. In addition, FDA 

recommends providing information 

related to the stage of product 

development (e.g., the status of any 

study(ies) in which a product/new use 

is being investigated and how it relates 

to the overall product development 

plan; whether a marketing application 

for the product or new use has been 

submitted to FDA or when such a 

submission is planned). FDA also 

recommends that communications that 

include factual presentations of results 

from studies also describe material 

aspects of study design and 

methodology and disclose material 

limitations related to the study design, 

methodology, and results. Moreover, 

FDA recommends that firms provide 

followup information to payors if 

previously communicated information 

becomes materially outdated as a result 

of significant changes or as a result of 

new information regarding the product 

or its review status. 

Description of Respondents: For 

information that should be included 

when HCEI about approved prescription 

drugs is disseminated to payors, 

respondents to this collection of 

information are firms that manufacture 

prescription human drugs products, 

including biological products; for 

information that should be included 

when HCEI about approved or cleared 

medical devices is disseminated to 

payors, respondents to this collection of 

information are firms that manufacture 

medical devices; for information that 

should be included in communications 

with payors about unapproved products 

and about unapproved uses of 

approved/cleared products, respondents 

to this collection of information are 

firms that manufacture prescription 

human drug products, including 

biological products, and medical 

devices. 

As noted, in the Federal Register of 

January 19, 2017, 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 recommendations found 

in the draft guidance. Although no 

comments were received in response to 

the four information collection topics 

solicited in the notice, we revised the 

guidance as discussed above. These 

revisions resulted in a significant 

increase to the number of respondents 

to the information collection and also 

recommended new data elements. 

However, because our estimate reflects 

the average burden of the information 

collection distributed among all 

respondents, we believe any increase 

resulting from revisions to the guidance 

would be nominal. 

Based on the post-marketing 

submissions of promotional materials 

using Form FDA 2253 received in 

calendar year 2016 for approved human 

prescription drugs, including 

prescription biological products, FDA 

estimates that approximately 440 

manufacturers will disseminate 4,400 

distinct HCEI materials for approved 

human prescription drugs annually. 

FDA estimates that approximately 236 

manufacturers will disseminate 2,360 

distinct HCEI materials for approved/ 

cleared devices annually. FDA estimates 

it will take firms approximately 20 

hours to compile and draft the 

information that this final guidance 

recommends should be included when 

disseminating HCEI materials for 

approved human prescription drugs and 

approved/cleared devices. Based on the 

number of human prescription drugs 

and devices approved/cleared and the 

number of efficacy supplements 

approved/cleared (i.e., approving/ 

clearing a new use for an approved/ 

cleared product) in a calendar year, FDA 

estimates that approximately 717 

manufacturers will prepare 1,434 

distinct communications of information 

to payors about their unapproved 

products or unapproved uses of 

approved/cleared products annually. 

FDA estimates it will take firms 

approximately 0.5 hour to compile and 

draft the information that this final 

guidance recommends should be 

provided with communications to 

payors about unapproved products or 

unapproved uses of approved/cleared 

products. Additionally, FDA estimates 

that 50 percent of the firms will spend 

approximately 2 hours to compile and 

provide 718 distinct communications of 

followup information regarding 

previously communicated information 

to payors about their unapproved 

products or unapproved uses of 

approved/cleared products annually. 

We therefore estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of information Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Recommended information to be included when firms 

choose to disseminate HCEI materials to payors about 

approved prescription drugs.

440 10 4,400 20 ................... 88,000 


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Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27609 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Type of information Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Recommended information to be included when firms 

choose to disseminate HCEI materials to payors about 

approved or cleared medical devices.

236 10 2,360 20 ................... 47,200 

Recommended information to be included when firms 

choose to disseminate information about unapproved 

products or unapproved uses of approved or cleared 

products.

717 2 1,434 .5 (30 minutes) 717 

Followup information to payors regarding previously communicated about unapproved products or unapproved 

uses of approved or cleared products.

359 2 718 2 ..................... 1,436 

Total .............................................................................. ........................ ........................ ........................ ........................ 137,353 

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

This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR 314.81(b)(3)(i) (Form FDA 2253) 

have been approved under OMB control 

number 0910–0001. 

FDA is issuing this final guidance 

subject to OMB approval of the 

collections 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 

collections 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 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, or 

https://www.regulations.gov. 

Dated: June 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12632 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–2018–N–2065] 

Alternative or Streamlined 

Mechanisms for Complying With the 

Current Good Manufacturing Practice 

Requirements for Combination 

Products; Proposed List Under the 

21st Century Cures Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: As required by the 21st 

Century Cures Act (Cures Act), the Food 

and Drug Administration (FDA or 

Agency) is proposing a list of alternative 

or streamlined mechanisms for 

complying with the current good 

manufacturing practice (CGMP) 

requirements for combination products. 

Combination products are products 

composed of two or more different types 

of medical products (drug, device, and/ 

or biological product). 

DATES: Submit either electronic or 

written comments on this notice by 

September 11, 2018 to ensure that the 

Agency considers your comment on this 

proposed list before it begins work on 

the final list. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before September 11, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of September 11, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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 


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