49832 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

[FR Doc. 2017–23447 Filed 10–26–17; 8:45 am] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1076] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection in the guidance on ‘‘Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 26, 2017. 

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 December 26, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 26, 2017. 

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 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–1076 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Guidance 

for Industry on Formal Dispute 

Resolution: Scientific and Technical 

Issues Related to Pharmaceutical 

Current Good Manufacturing Practice.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 49833 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry on Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice 

OMB Control Number 0910–0563— 

Extension 

This information collection supports 

the guidance for industry on ‘‘Formal 

Dispute Resolution: Scientific and 

Technical Issues Related to 

Pharmaceutical Current Good 

Manufacturing Practice.’’ The guidance 

is available at: https://www.fda.gov/ 

downloads/drugs/guidances/ 

ucm070279.pdf. The guidance informs 

manufacturers of veterinary and human 

drugs, including human biological drug 

products, on how to resolve disputes 

about scientific and technical issues 

relating to current good manufacturing 

practice (CGMP). Disputes related to 

scientific and technical issues may arise 

during FDA inspections of 

pharmaceutical manufacturers to 

determine compliance with CGMP 

requirements or during FDA’s 

assessment of corrective actions 

undertaken as a result of such 

inspections. The guidance provides 

procedures that encourage open and 

prompt discussion of disputes and lead 

to their resolution. The guidance 

describes procedures for raising such 

disputes to the Office of Regulatory 

Affairs (ORA) and center levels and for 

requesting review by the dispute 

resolution (DR) panel. 

When a scientific or technical issue 

arises during an FDA inspection, the 

manufacturer should initially attempt to 

reach agreement on the issue informally 

with the investigator. Certain scientific 

or technical issues may be too complex 

or time consuming to resolve during the 

inspection. If resolution of a scientific or 

technical issue is not accomplished 

through informal mechanisms before the 

issuance of Form FDA 483, the 

manufacturer can formally request DR 

and use the two-tiered DR process 

described in the guidance. 

Tier one of the formal DR process 

involves a manufacturer raising 

scientific or technical issues to the ORA 

and center levels. If a manufacturer 

disagrees with the tier-one decision, tier 

two of the formal DR process would 

then be available for appealing that 

decision to the DR panel. The written 

request for formal DR to the appropriate 

ORA unit should be made within 30 

days of the completion of an inspection 

and should include all supporting 

documentation and arguments for 

review, as described in this document. 

The written request for formal DR to the 

DR panel should be made within 60 

days of receipt of the tier-one decision 

and should include all supporting 

documentation and arguments, as 

described in this document. 

All requests for formal DR should be 

submitted in writing and include 

adequate information to explain the 

nature of the dispute and to allow FDA 

to act quickly and efficiently. Each 

request should be sent to the 

appropriate address listed in the 

guidance and include the following 

elements: 

• Cover sheet that clearly identifies 

the submission as either a tier-one or 

tier-two DR request. 

• Name and address of manufacturer 

inspected (as listed on Form FDA 483). 

• Date of inspection (as listed on 

Form FDA 483). 

• Date Form FDA 483 was issued (as 

listed on Form FDA 483). 

• Facility Establishment Identifier 

number, if available (as listed on Form 

FDA 483). 

• Names and titles of FDA employees 

who conducted inspection (as listed on 

Form FDA 483). 

• Office responsible for the 

inspection (e.g., district office, as listed 

on Form FDA 483). 

• Application number if the 

inspection was a preapproval 

inspection. 

• Comprehensive statement of each 

issue to be resolved: 

Æ Identify the observation in dispute. 

Æ Clearly present the manufacturer’s 

scientific position or rationale 

concerning the issue under dispute with 

any supporting data. 

Æ State the steps that have been taken 

to resolve the dispute, including any 

informal DR that may have occurred 

before the issuance of Form FDA 483. 

Æ Identify possible solutions. 

Æ State expected outcome. 

• Name, title, telephone and fax 

numbers, and email address (as 

available) of manufacturer contact. 

The guidance responds to industry’s 

request for a formal DR process to 

resolve differences related to scientific 

and technical issues that arise between 

investigators and pharmaceutical 

manufacturers during FDA inspections 

of foreign and domestic manufacturers. 

In addition to encouraging 

manufacturers to use currently available 

DR processes, the guidance describes 

the formal two-tiered DR process 

explained previously. The guidance also 

covers the following topics: 

• Suitability of certain issues for the 

formal DR process, including examples, 

with a discussion of their 

appropriateness for the DR process. 

• Instructions on how to submit 

requests for formal DR, and a list of the 

supporting information that should 

accompany these requests. 

• Public availability of decisions 

reached during the DR process to 

promote consistent application and 

interpretation of regulations related to 

drug quality. 

We estimate the burden for the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Requests for tier-one DR ..................................................... 2 1 2 30 60 

Requests for tier-two DR ..................................................... 1 1 1 8 8 

Total .............................................................................. ........................ ........................ ........................ ........................ 68 

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


asabaliauskas on DSKBBXCHB2PROD with NOTICES
49834 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices 

As reflected in table 1, we estimate 

two manufacturers will submit two 

requests annually for tier-one DR, and 

that there will be one appeal of these 

requests to the DR panel (tier-two DR). 

We estimate also that it will take 

manufacturers approximately 30 hours 

to prepare and submit each request for 

a tier-one DR, and approximately 8 

hours to prepare and submit each 

request for a tier-two DR. Based on our 

experience with this collection we have 

not changed our estimate since our last 

request for OMB approval. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23444 Filed 10–26–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–3710] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Evaluation of the 

Food and Drug Administration’s 

Education at the Point of Sale 

Campaign 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is 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: Fax written comments on the 

collection of information by November 

27, 2017. 

ADDRESSES: To ensure that 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 ‘‘Evaluation of FDA’s Education at 

the Point of Sale Campaign.’’ Also, 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Evaluation of FDA’s Education at the 

Point of Sale Campaign OMB Control 

Number 0910—NEW 

The 2009 Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Pub. L. 111–31) amends 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) to grant FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health and to 

reduce tobacco use by minors. Section 

1003(d)(2)(D) of the FD&C Act (21 

U.S.C. 393(d)(2)(D)) supports the 

development and implementation of 

FDA public education campaigns 

related to tobacco use. Accordingly, 

FDA is currently developing and 

implementing a tobacco education 

intervention at the point of sale to 

reduce the public health burden of 

tobacco use. The campaign features 

advertisements intended to encourage 

future quit attempts among current 

smokers in stores that sell tobacco 

products. 

In support of the provisions of the 

Tobacco Control Act that require FDA to 

protect the public health, FDA requests 

OMB approval to collect information to 

evaluate the effectiveness of the point of 

sale tobacco education campaign. Data 

from this outcome evaluation study will 

be used to examine statistical 

associations between exposure to the 

campaign and specific outcomes of 

interest, which include awareness of the 

campaign and its messaging, tobaccorelated attitudes, beliefs and risk 

perceptions, and motivation to quit 

smoking. 

Evaluation is an essential 

organizational practice in public health 

and a systematic way to account for and 

improve public health actions. 

Comprehensive evaluation of FDA’s 

public education campaigns will be 

used to document whether the intended 

audience is aware of and understands 

campaign messages, and whether 

campaign exposure influences tobaccorelated attitudes, beliefs and risk 

perceptions, intentions to use tobacco, 

and motivation to quit smoking. 

Participation in the outcome evaluation 

study will be voluntary. All of the 

information collected is integral to that 

evaluation. 

Evaluation of the Point of Sale 

Campaign. This outcome evaluation 

study will consist of four longitudinal 

data collection periods over 24 months 

(approximately every 7 months), with 

the first survey (Wave 1) occurring 

approximately 3 months after campaign 

launch. A fourth wave of data collection 

has been added to the three proposed in 

the 60-day notice because the campaign 

has been extended from 18 to 24 

months. The additional wave of data 

collection is necessary to continue to 

assess the impact of the campaign. To 

reduce the number of participants 

needed to detect the effects of the 

campaign on outcomes of interest, the 

design of the campaign was changed 

from two treatment groups and one 

control group to one treatment group 

and one control group. The respondent 

numbers and burden hours below have 

been revised to reflect the four data 

collection waves and the change in the 

number of treatment groups. 

Information will be collected from 

adult cigarette smokers, ages 25 to 54, 

about awareness of and exposure to 

campaign advertisements, tobacco use, 

and knowledge, attitudes, and beliefs 

related to tobacco use. Information will 

be collected on demographic variables 

including age, sex, race/ethnicity, and 

primary language. Participants will also 

be offered the option to download a 

smartphone application that will track 

their exposure to the campaign, and that 

will ask them to respond to a brief 

survey about every 6 months over 18 

months. 

FDA’s media contractor identified 37 

potential counties for the campaign. 

From this list, FDA’s evaluation 

contractor has selected 30 counties to be 

included in the evaluation. Of these, 15 

counties will receive the intervention 

(treatment counties), and 15 counties 

will not receive it (control counties). 

The number of counties has changed 

since the 60-day notice because we 

changed the experimental design to 

have one treatment group instead of 

two, which resulted in needing fewer 

counties. 

Data will be collected from a 

longitudinal cohort that will consist of 

an entirely new sample of adult 

cigarette smokers. Addresses will be 

randomly selected from postal carrier 

routes in the 30 selected U.S. counties 

to identify households that contain one 

or more adult smokers between the ages 

of 25 and 54. Pre-paid pre-addressed 

paper screening surveys will be mailed 

to approximately 104,541 households. 

We estimate that 27,651 (9,217 

annualized respondents) households 

will return the 10-minute screener they 

received by mail, and 26,258 (8,753 


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