64394 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

600.80(c)(1) and 600.80(i) ................................................... 131 1,718.60 225,137 1 225,137 

Total .............................................................................. ........................ ........................ ........................ ........................ 485,817 

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

2The recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12. 

Dated: October 23, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25637 Filed 10–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1009] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Information 

Request Regarding pH of Smokeless 

Tobacco Products 

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 

28, 2014. 

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 ‘‘Information Request Regarding pH 

of Smokeless Tobacco Products.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Information Request Regarding pH of 

Smokeless Tobacco Products—(OMB 

Control Number 0910–NEW) 

On June 22, 2009, President Obama 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

Control Act) (Pub. L. 111–31) into law. 

The Tobacco Control Act amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by granting FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health 

generally and to reduce tobacco use by 

minors. 

Section 904(b) of the FD&C Act (21 

U.S.C. 387d(b)) states that at the request 

of the Secretary, each tobacco product 

manufacturer or importer, or agents 

thereof, must submit: 

• Any or all documents (including 

underlying scientific information) 

relating to research activities, and 

research findings, conducted, 

supported, or possessed by the 

manufacturer (or agents thereof) on the 

health, toxicological, behavioral, or 

physiological effects of tobacco products 

and their constituents (including smoke 

constituents), ingredients, components, 

and additives. 

• Any or all documents (including 

underlying scientific or financial 

information) relating to research 

activities, and research findings, 

conducted, supported, or possessed by 

the manufacturer (or agents thereof) that 

relate to the issue of whether a 

reduction in risk to health from tobacco 

products can occur upon the 

employment of technology available or 

known to the manufacturer. 

• Any or all documents (including 

underlying scientific or financial 

information) relating to marketing 

research involving the use of tobacco 

products or marketing practices and the 

effectiveness of such practices used by 

tobacco manufacturers and distributors. 

If the Secretary requests information 

from the manufacturer of a tobacco 

product not manufactured in the United 

States, the importer of the tobacco 

product is required to supply the 

information. FDA is requesting OMB 

approval of an information collection 

under section 904(b) of the FD&C Act. 

To become better informed about the 

impact of the use of tobacco products on 

the public health, FDA would request 

information about the effects of product 

pH in smokeless tobacco products from 

all tobacco product manufacturers. FDA 

would send letters to tobacco product 

manufacturers and importers who FDA 

has identified as having an obligation to 

respond based on information before the 

Agency. The requested information 

would include information about 

research requested under section 904(b) 

of the FD&C Act as well as information 

to be provided voluntarily beyond the 

inquiries described in section 904(b). 

I. Information Requested 

The proposed request would include 

the following information: 

All documents (including underlying 

scientific information and financial 

information) relating to research 

activities and research findings 

conducted, supported, or possessed by 

the respondent or the respondent’s 

agents relating to a specified set of 

topics listed in this document. The 

request includes but is not limited to 

documents relating to research findings 

and activities, if any, that the 

respondent possesses as the result of 

acquiring or merging with another 

company. For purposes of the request, 

‘‘research’’ would include, but would 

not be limited to, focus groups, surveys, 

experimental clinical studies, 

toxicological and biochemical assays, in 

vivo and in vitro assays including 

animal testing, laboratory formulation 

and processing testing, taste panels, and 

assessments of the effectiveness of 

product marketing practices. The 

request would apply to research relating 

to any and all smokeless tobacco 

products, including but not limited to 

those products for research, 

investigational use, developmental 

studies, test marketing, and/or 

commercial marketing, and also to the 

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Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 64395 

components, parts, or accessories of 

such products. For products not 

manufactured in the United States, the 

request would apply to the extent the 

respondent has imported such products 

into the United States. 

II. Topics 

Under section 904(b) of the FD&C Act, 

FDA would request all documents and 

underlying scientific and financial 

information relating to research 

activities, research findings, and 

marketing research for smokeless 

tobacco products developed since 

January 1, 1980, on the following topics: 

• The effect of product pH on ratio of 

free/bound (unprotonated/protonated) 

nicotine; 

• the effect of product pH on user 

behavior; 

• the effect of product pH on user 

subjective effects and experiences 

including, but not limited to, sensory 

effects in the mouth and throat, liking, 

craving and withdrawal symptoms, 

stimulation, concentration, and anxiety; 

• the effect of product pH on user 

physiological responses including, but 

not limited to, heart rate, blood 

pressure, temperature, and nicotine 

pharmacokinetics; and 

• for smokeless tobacco products that 

have a pH of 7.2 or less, marketing 

research that includes attractiveness or 

appeal to new users, inexperienced 

users, and/or to persons under the age 

of 25. 

Research and development of 

methodology for adjusting the pH of 

smokeless tobacco products would be 

specifically excluded from this 904(b) 

request. 

III. Limitations on Types of Documents 

and Information 

With respect to the topics listed, FDA 

would request only the following 

documents and information: 

• Study proposals, original 

implemented protocols (including all 

amendments), analysis plans, 

agreements, notebooks, data collection 

tools, including but not limited to, 

forms and assessment scales for 

planned, ongoing, or completed studies, 

surveys, and other research, whether for 

external release or internal use; 

• final data analyses and reports 

regarding studies, surveys, data 

compilations, or other research, whether 

for external or internal use (if there were 

no final analyses, interim data analyses 

would be included in the request); 

• posters and/or presentations 

exhibited or to be exhibited at external 

meetings or conferences if the 

underlying data has not been presented 

in other documents and information 

within the request; 

• manuscripts, articles, editorials, 

and letters that have been submitted for 

publication but not yet published (e.g., 

in review, accepted, rejected); and 

• underlying data (e.g., in the form of 

spreadsheets, datasets, charts, tables, 

and diagrams) analyzed to produce any 

of the data analyses, reports, posters, 

manuscripts, or articles requested 

previously in this notice. 

FDA would request only the final 

versions of documents, or in the absence 

of a final version, the most recent draft 

of each document. Published (i.e., 

publically available) press releases, 

abstracts, editorials, letters, 

manuscripts, material safety data sheets, 

and Department of Health and Human 

Services correspondences, would not be 

requested, although FDA would 

appreciate a list of such publications 

provided as a separate appendix. Data 

supporting summary reports would be 

included in the request, and FDA would 

ask that spreadsheets or datasets be 

submitted both in PDF and in a file type 

and structured format that allows for 

meaningful review and analysis of the 

data (e.g., Excel (.xls), comma separated 

values (.csv), or SAS transport (.xpt) file 

formats). Also, FDA would request 

relevant data submissions be 

accompanied by the name and version 

of the software used to create the file, 

and names and definitions of variables 

and copies of programs and macros 

needed to generate the analyses. FDA 

would also ask that respondents include 

any data analyses that stratify scientific 

results by gender, race, ethnicity, age, or 

other similar factors. 

To provide context and background 

for each document, FDA would ask the 

respondent to include a load file 

containing metadata (e.g., manufacturer, 

date, author(s)) for each document. Also 

in the metadata load file, FDA would 

ask the respondents to identify the 

presence of each document in the 

University of California San Francisco 

Legacy Tobacco Documents Library 

(LTDL) as one of the following: Present 

with the Bates number (begin Bates 

number to end Bates number), not 

present, or unknown. 

As an option, information responsive 

to the request that has been previously 

provided to FDA under sections 

904(a)(1), 904(a)(3), 904(c)(1), 904(c)(2), 

or 904(c)(3) of the FD&C Act would not 

have to be resubmitted as long as the 

document was fully referenced in the 

metadata load file. 

IV. Additional Information 

FDA would ask the respondent to 

submit voluntarily the following 

additional information, as applicable, to 

provide context and background for 

FDA: 

• A summary (one to five pages in 

length) for each of the topics previously 

mentioned in this notice, that includes 

the number and type of documents 

included, and a high level overview of 

the content; and 

• an explanation of the scientific and 

business reasons, rationale, or 

justification for developing and 

marketing smokeless tobacco products 

with different pH values, including 

expected and observed perception and 

behavior of current and potential 

consumers. 

This is a new collection of 

information. FDA would use the 

information to assess the effects of pH 

of smokeless tobacco products on 

consumers and the public health. In the 

Federal Register of July 23, 2014 (79 FR 

42797), FDA published a 60-day notice 

requesting public comment on the 

proposed collection of information. 

Four commenters submitted nine 

comments that were PRA related. 

(Comment 1) The Agency should 

request all document versions, 

including drafts, as well as comments 

on those versions and reasons for 

changes made in subsequent versions. 

(Response) FDA believes the request 

to prepare a submission that includes 

drafts including related metadata will be 

overly burdensome for the respondent. 

Additionally, a request to be provided 

the reason for changes made in 

subsequent versions is beyond the 

inquiries described in section 904(b). 

FDA clarified the request to note the 

original implemented protocol is to be 

submitted. FDA would contact 

manufacturers, if additional information 

is needed to facilitate the Agency’s 

review of the submission. 

(Comment 2) Do not limit the request 

to SAS datasets as to not exclude other 

statistical software. 

(Response) It is FDA’s intent that data 

not be excluded from the request based 

upon the statistical analysis software 

used. The proposed request asks that 

data be provided in a file type and 

structured format that allows for 

meaningful review and analysis of the 

data. The request was clarified to note 

that SAS.xpt is a recommended format 

for datasets. 

(Comment 3) The Agency should 

request the LTDL tobacco identification 

(TID) number or URL since these are 

unique to the document. 

(Response) Because the manufacturer 

does not assign the TID number or URL, 

FDA believes requesting this 

information would be overly 

burdensome for the respondent and 

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64396 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 

therefore would request only the Bates 

number(s) as proposed, given that this 

information is assigned by the 

manufacturer. 

(Comment 4) It would be overly 

burdensome for the respondent to locate 

data and provide the requested software 

for information dating back to January 1, 

1970, and FDA should focus the 

information for more recent times. 

(Response) FDA believes the time 

period for this request should coincide 

with the commercial availability of 

smokeless tobacco products with 

different pH values because industry 

research on this topic is limited in the 

public domain. FDA has considered the 

scientific value of the data and 

information as well as the burden on 

respondents to provide such 

information to FDA. Therefore, FDA 

revised the request to ask for documents 

developed since January 1, 1980. 

(Comment 5) The burden for the 

collection was underestimated given 

that it is likely older documents may 

only exist in hard copy and, if found, 

would be in remote storage that would 

be mostly searched manually. 

(Response) The burden was revised 

given that this portion of the request 

may be performed manually. 

(Comment 6) The burden for the 

collection was underestimated given 

that respondents would need to perform 

document-by-document search of a 

third party site to provide the requested 

metadata from LTDL. 

(Response) The burden was revised 

given that this portion of the request 

may be performed manually. 

(Comment 7) It would be overly 

burdensome for respondents to provide 

the amount of metadata requested for 

documents previously submitted to FDA 

in lieu of providing the Agency with all 

of the responsive documents it locates. 

(Response) FDA clarified the purpose 

of the metadata load file and also 

clarified that the respondent has the 

option to provide metadata for 

previously submitted documents. 

(Comment 8) It would take at least 90 

days to provide a response to the 

request. 

(Response) Given the Agency’s 

experience with previous submissions 

under section 904(a)(4) and 904(b) of the 

FD&C Act, FDA would request a 

response within 60 days from the date 

of the letter and request respondents 

that anticipate difficulties with the 

document production to contact FDA 

within 30 days of the date of the letter. 

FDA will provide assistance in resolving 

any technical difficulties and facilitate 

compliance with the timeline. 

(Comment 9) The Agency previously 

estimated an average of 200 hours per 

response for the Agency’s request for 

dissolvable tobacco products in 2011. 

(Response) FDA has since learned 

from experience with document 

submissions under section 904(a)(4) and 

904(b) of the FD&C Act that some 

respondents have electronic document 

systems. Thus, estimates for this 

collection reflect automation 

capabilities for processing and 

managing document submissions. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent gathering 

product pH information 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden hours 

per response 

Total hours Total capital 

costs 

Tobacco product manufacturers and importers with LTDL collections ............... 3 1 3 165 495 $29 

Additional tobacco product manufacturers and importers with previous submissions to FDA ................................... 3 1 3 175 525 186 

Other manufacturers who have no documents, do not manufacture smokeless 

tobacco products, or do not anticipate 

manufacturing these products .............. 119 1 119 5 595 59 

Total .................................................. ........................ ........................ ........................ ........................ 1,615 274 

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

We estimate the capital costs 

associated with this document to be 

$274. This estimate is based upon: (1) 3 

Submissions being submitted by mailing 

an average of 10 CDs per envelope ($29), 

(2) 3 submissions being submitted by 

mailing a package of paper documents 

weighing an average of 50 pounds total 

($186), and (3) 119 submissions of 1 

business class letter describing that no 

documents are available (119 × $0.49 

(the price of a first class business 

stamp), or $59). 

FDA is drawing from tobacco health 

document submissions under section 

904(a)(4) and 904(b) of the FD&C Act, 

our interaction with the public, and our 

experience to inform the burden 

estimates associated with this 

information collection. Additionally, 

based upon comments in response to 

the Federal Register notice, FDA is 

revising its initial estimates of 

annualized burden hours. 

FDA estimates the burden for this 

collection of information to be 1,615 

hours. FDA estimates it will receive 125 

submissions. Based upon the expected 

number of tobacco product 

manufacturers and importers, their 

burden has been broken into three tiers: 

• FDA anticipates documents for this 

request will be submitted by three 

tobacco product manufacturers and 

importers that have document 

collections within LTDL. Manufacturers 

one through three were estimated to 

take 201, 206, and 85 hours 

respectively, for an approximate average 

of 165 hours per response, to process 

and prepare a submission (i.e., cover 

letter, documents and information, and 

metadata load file). Total burden hours 

for this portion of the collection are 

expected to be 495 hours. 

• FDA anticipates documents to also 

be submitted by three additional 

tobacco product manufacturers and 

importers that provided health 

documents under section 904(a)(4). 

Manufacturers four through six were 

estimated to take 304, 118, and 91 hours 

respectively, for an approximate average 

of 175 hours per response, to process 

and prepare a submission (i.e., cover 

letter, documents and information, and 

metadata load file). Total burden hours 

for this portion of the collection are 

expected to be 525 hours. 

• FDA estimates that 119 

manufacturers and importers will not 

possess documents responsive to this 

request. These manufacturers do not 

have documents, do not manufacture 

smokeless tobacco products, or do not 

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Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 64397 

anticipate manufacturing these tobacco 

products and are estimated to take 

approximately 5 hours each to conduct 

a review of their records, draft and send 

a letter to FDA indicating that they do 

not have documents to submit. Total 

burden hours for this portion of the 

collection are expected to be 595 hours. 

Dated: October 23, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25638 Filed 10–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1575] 

Best Practices for Communication 

Between the Food and Drug 

Administration and Investigational 

New Drug Sponsors During Drug 

Development; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of docket, 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a docket to receive 

suggestions, recommendations, and 

comments from interested parties, 

including academic institutions, 

regulated industry, and other interested 

organizations on best practices for 

communication between FDA and 

investigational new drug application 

(IND) sponsors during drug 

development. These comments will 

help FDA identify and ultimately 

establish best practices to be included in 

a draft guidance for industry and review 

staff. 

DATES: Submit either electronic or 

written comments by December 29, 

2014. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel E. Hartford, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6312, 

Silver Spring, MD 20993–0002, 301– 

796–0331, email: 

ONDEnhancedComm@fda.hhs.gov; 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

One of FDA’s performance 

commitments made as part of the fifth 

authorization of the Prescription Drug 

User Fee Act (PDUFA) under Title I of 

the Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144), related to promoting innovation 

through enhanced communication 

between FDA and sponsors during drug 

(including biological product) 

development, is for FDA to publish draft 

guidance for industry and review staff 

describing best practices for 

communication between FDA and IND 

sponsors during drug development. (A 

copy of the PDUFA Reauthorization 

Performance Goals and Procedures; 

Fiscal Years 2013 Through 2017 is 

available on the FDA Web site at 

http://www.fda.gov/downloads/

forindustry/userfees/

prescriptiondruguserfee/

ucm270412.pdf.) 

The guidance will describe FDA’s 

philosophy regarding timely interactive 

communication with IND sponsors as a 

core activity and the scope of 

appropriate interactions between the 

review team and the sponsor, outline 

the types of advice that are appropriate 

for sponsors to seek from FDA in 

pursuing their drug development 

program, describe the general 

expectations for the timing of FDA 

response to IND sponsor inquiries of 

simple and clarifying questions or 

referral of more complex questions to 

the formal meeting process, and 

describe best practices and 

communication methods (including the 

value of person-to-person scientific 

dialogue) to facilitate interactions 

between the FDA review team and the 

IND sponsor during drug development. 

We anticipate that the best practices 

will include expectations and agreement 

on appropriate methods (e.g., when 

teleconferencing or secure email may be 

the most appropriate means of 

communication) and frequency of such 

communications. 

II. Establishment of a Docket and 

Request for Comments 

To help FDA identify and ultimately 

establish best practices to be included in 

a draft guidance, FDA is requesting 

public suggestions, recommendations, 

and comments for each aspect of the 

best practices mentioned above. FDA 

will consider all comments submitted. 

FDA generally will not respond directly 

to the person or organization submitting 

the comment. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: October 22, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–25641 Filed 10–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

Solicitation of Information and 

Recommendations for Revising OIG’s 

Non-Binding Criteria for Implementing 

Permissive Exclusion Authority Under 

Section 1128(b)(7) of the Social 

Security Act 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Notice; Extension of comment 

period. 

SUMMARY: This document announces an 

extension of the public comment period 

for the OIG Federal Register notice 

published on July 11, 2014 (79 FR 

40114). The notice solicited input from 

the public on revising the criteria used 

by OIG in implementing its permissive 

exclusion authority under Section 

1128(b)(7) of the Social Security Act. 

Due to a technical problem, the public 

may have been unable to submit 

comments at http://www.regulations.gov 

during the comment period. 

Accordingly, we are extending the 

comment period to ensure that the 

public has an opportunity to provide 

input. 

DATES: To ensure consideration, public 

comments must be delivered to the 

address provided below by no later than 

5 p.m. on December 29, 2014. 

ADDRESSES: In commenting, please refer 

to file code OIG–1271–N. Because of 

staff and resource limitations, we cannot 

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