20026 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

6004. The draft guidance notifies 

entities covered by section 6004 that 

FDA does not intend to object until at 

least October 1, 2012, if manufacturers 

and ADRs do not submit information 

under section 6004 and that we intend 

to provide notice before revising our 

exercise of discretion with respect to 

compliance. The draft guidance also 

notifies covered entities that FDA plans 

to use its Electronic Submission 

Gateway (the Gateway) for submissions 

under section 6004 and that revisions to 

allow the Gateway to receive such 

submissions should be complete by 

April 1, 2012. Should covered entities 

wish to make such submissions 

notwithstanding FDA’s compliance 

policy, the draft guidance provides 

information about accessing the 

Gateway. The Agency expects to issue 

further draft guidance concerning the 

requirements of section 6004 later in 

2012. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

III. Paperwork Reduction Act of 1995 

This draft guidance regarding Agency 

compliance policy refers to information 

collections under section 6004 that are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). As 

noted, the Agency is also preparing a 

draft guidance for release later this year 

to provide additional information 

regarding submissions under section 

6004. In accordance with the PRA, prior 

to publication of a final guidance 

document, FDA intends to solicit public 

comment and obtain OMB approval for 

any new information collections under 

section 6004. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, http://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: March 28, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7912 Filed 3–29–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0071] 

Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications; 

Availability; Agency Information 

Collection Activities; Proposed 

Collection; Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Modified Risk 

Tobacco Product Applications.’’ The 

draft guidance provides information 

about submitting applications for 

modified risk tobacco products under 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). The draft guidance 

describes the information that the FD&C 

Act requires you to submit in your 

modified risk tobacco product 

application and the scientific evidence 

FDA recommends you submit to 

support your application. The draft 

guidance also permits the filing of a 

single application for any modified risk 

tobacco product that is also a new 

tobacco product under the FD&C Act. 

DATES: Although you can submit written 

or electronic comments on this guidance 

at any time (see 21 CFR 10.115(g)(5)), to 

ensure that the Agency considers your 

comment on this draft guidance before 

it begins work on the final version of the 

guidance, submit electronic or written 

comments on the draft guidance by June 

4, 2012. Submit electronic or written 

comments on the proposed collection of 

information by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Modified Risk 

Tobacco Product Applications’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the draft guidance may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance, including comments on 

the proposed collection of information, 

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: 

With regard to the draft guidance: Gail 

Schmerfeld or Kristin Davis, Center for 

Tobacco Products, 9200 Corporate 

Blvd., Rockville, MD 20850–3229, 1– 

877–287–1373, 

gail.schmerfeld@fda.hhs.gov or 

kristin.davis@fda.hhs.gov. 

With regard to the proposed collection 

of information: Daniel Gittleson, Office 

of Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–5156, 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Pub. L. 111– 

31) (Tobacco Control Act) into law. The 

Tobacco Control Act grants FDA 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect public health 

generally and to reduce tobacco use by 

minors. Congress found that it is 

essential that, prior to marketing 

tobacco products for use to reduce harm 

or the risk of tobacco-related disease or 

to reduce exposure to harmful 

substances associated with tobacco 

products, manufacturers be required to 

‘‘demonstrate that such products * * * 

meet a series of rigorous criteria, and 

will benefit the health of the population 

as a whole’’ (section 2(36) of the 

Tobacco Control Act). Thus, section 101 

of the Tobacco Control Act added 

section 911 (21 U.S.C. 387k) to the 

FD&C Act to prohibit the introduction 

or delivery for introduction into 

interstate commerce of any modified 

risk tobacco product unless an order 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20027 

issued by FDA pursuant to section 

911(g) of the FD&C Act is effective with 

respect to such product. A modified risk 

tobacco product is any tobacco product 

that is sold or distributed for use to 

reduce harm or the risk of tobaccorelated disease associated with 

commercially marketed tobacco 

products (section 911(b)(1) of the FD&C 

Act). 

Section 911(l)(1) of the FD&C Act 

directs FDA to issue regulations or 

guidance (or any combination thereof) 

on the scientific evidence required for 

assessment and ongoing review of 

modified risk tobacco products. FDA is 

issuing this draft guidance in 

compliance with section 911(l)(1). 

When finalized, the draft guidance will 

provide industry with information on 

who submits modified risk tobacco 

product applications (MRTPAs), when 

to submit a MRTPA, what information 

section 911 of the FD&C Act requires 

applicants to submit in a MRTPA, what 

scientific evidence FDA recommends 

applicants include in a MRTPA, what 

information should be collected through 

postmarket surveillance and studies, 

how to organize and submit the 

MRTPA, and FDA’s timeframe for 

review of a MRTPA. It will also provide 

for the filing of a single application for 

any modified risk tobacco product that 

is also a new tobacco product. 

Section 911(l)(2) of the FD&C Act 

directs FDA to consult with the Institute 

of Medicine (IOM), and get the input of 

other appropriate scientific and medical 

experts, on the design and conduct of 

studies required for the assessment and 

ongoing review of modified risk tobacco 

products. FDA gave IOM its charge on 

February 2, 2011. IOM published its 

report on December 14, 2011. The report 

is available through http:// 

www.iom.edu/Reports/2011/ScientificStandards-for-Studies-on-ModifiedRisk-Tobacco-Products.aspx and will be 

placed in the docket for this draft 

guidance. In order to get input from 

other experts, FDA held a public 

workshop on August 25 and 26, 2011, 

and established a docket, FDA–2011–N– 

0443, to receive public comments. FDA 

intends to consider the IOM report and 

comments submitted to the public 

workshop docket in preparing the final 

guidance. 

II. Significance of Guidance 

FDA is issuing this draft guidance 

document consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on ‘‘Modified Risk 

Tobacco Product Applications.’’ It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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 

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. 

Draft Guidance for Industry: Modified 

Risk Tobacco Product Applications 

(OMB Control Number 0910–NEW) 

This draft guidance describes the 

information that the FD&C Act requires 

you to submit in your MRTPA as well 

as FDA’s recommendations regarding 

the scientific evidence that should be 

contained in a MRTPA for FDA to make 

an assessment and conduct an ongoing 

review of modified risk tobacco 

products. The draft guidance also 

permits the filing of a single application 

for any modified risk tobacco product 

that is also a new tobacco product under 

section 910 of the FD&C Act. The draft 

guidance document discusses, among 

other things: Who submits MRTPAs, 

when to submit a MRTPA, what 

information section 911 of the FD&C Act 

requires applicants to submit in a 

MRTPA, what scientific evidence FDA 

recommends applicants include in a 

MRTPA, what information should be 

collected through postmarket 

surveillance and studies, and how to 

organize and submit a MRTPA. The 

purpose of the proposed information 

collection is to allow FDA to collect 

statutorily mandated information 

regarding modified risk tobacco 

products and other information that will 

facilitate FDA’s effective and efficient 

review of MRTPAs. 

Modified risk tobacco products are 

tobacco products that are sold or 

distributed for use to reduce harm or the 

risk of tobacco-related disease 

associated with commercially marketed 

tobacco products (section 911(b)(1) of 

the FD&C Act). No person may 

introduce or deliver for introduction 

into interstate commerce any modified 

risk tobacco product unless an order 

issued pursuant to section 911(g) of the 

FD&C Act is effective with respect to 

that product (section 911(a) of the FD&C 

Act). 

Under section 911(d) of the FD&C Act, 

a MRTPA must contain: 

• A description of the proposed 

product and any proposed advertising 

and labeling; 

• The conditions for using the 

product; 

• The formulation of the product; 

• Sample product labels and labeling; 

• All documents (including 

underlying scientific information) 

relating to research findings conducted, 

supported, or possessed by the tobacco 

product manufacturer relating to the 

effect of the product on tobacco-related 

diseases and health-related conditions, 

including information both favorable 

and unfavorable to the ability of the 

product to reduce risk or exposure and 

relating to human health; 

• Data and information on how 

consumers actually use the tobacco 

product; and 

• Such other information as the 

Secretary may require. 

Further, FDA’s regulation 

implementing the National 

Environmental Policy Act of 1969 

requires that ‘‘[a]ll applications or 

petitions requesting agency action 

require the submission of an 

[environmental assessment] or a claim 

of categorical exclusion’’ (21 CFR 

25.15(a)). 

Section 911(g) of the FD&C Act 

describes the demonstrations applicants 

must make to obtain an order from FDA. 

Sections 911(g)(1) and (2) of the FD&C 

Act set forth two bases for FDA to issue 

an order. 

mstockstill on DSK4VPTVN1PROD with NOTICES

20028 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

A ‘‘risk modification order’’ is an 

order permitting the introduction or 

delivery for introduction into interstate 

commerce of a tobacco product that 

FDA has found meets the criteria for an 

order under section 911(g)(1) of the 

FD&C Act. In order for FDA to issue a 

risk modification order under section 

911(g)(1) of the FD&C Act, the applicant 

must demonstrate that the proposed 

modified risk tobacco product, as it is 

actually used by consumers, will: 

• Significantly reduce harm and the 

risk of tobacco-related disease to 

individual tobacco users; and 

• Benefit the health of the population 

as a whole taking into account both 

users of tobacco products and persons 

who do not currently use tobacco 

products. 

An ‘‘exposure modification order’’ is 

an order permitting the introduction or 

delivery for introduction into interstate 

commerce of a tobacco product that 

reduces or eliminates exposure to a 

substance and for which the available 

scientific evidence suggests that a 

measurable and substantial reduction in 

morbidity and mortality is likely to be 

demonstrated in future studies. In order 

for FDA to issue an exposure 

modification order, the applicant must 

satisfy all of the criteria for issuance of 

an order under section 911(g)(2) of the 

FD&C Act. 

FDA may issue an exposure 

modification order under section 

911(g)(2) of the FD&C Act (the ‘‘special 

rule’’) if it determines that the applicant 

has demonstrated that: 

• Such an order would be appropriate 

to promote the public health; 

• Any aspect of the label, labeling, 

and advertising for the product that 

would cause the product to be a 

modified risk tobacco product is limited 

to an explicit or implicit representation 

that the tobacco product or its smoke 

does not contain or is free of a substance 

or contains a reduced level of a 

substance, or presents a reduced 

exposure to a substance in tobacco 

smoke; 

• Scientific evidence is not available 

and, using the best available scientific 

methods, cannot be made available 

without conducting long-term 

epidemiological studies for an 

application to meet the standards for 

obtaining an order under section 

911(g)(1); and 

• The scientific evidence that is 

available without conducting long-term 

epidemiological studies demonstrates 

that a measurable and substantial 

reduction in morbidity or mortality 

among individual tobacco users is 

reasonably likely in subsequent studies 

(section 911(g)(2)(A) of the FD&C Act). 

Furthermore, for FDA to issue an 

exposure modification order, FDA must 

find that the applicant has demonstrated 

that: 

• The magnitude of overall 

reductions in exposure to the substance 

or substances, which are the subject of 

the application is substantial, such 

substance or substances are harmful, 

and the product as actually used 

exposes consumers to the specified 

reduced level of the substance or 

substances; 

• The product as actually used by 

consumers will not expose them to 

higher levels of other harmful 

substances compared to the similar 

types of tobacco products then on the 

market unless such increases are 

minimal and the reasonably likely 

overall impact of use of the product 

remains a substantial and measurable 

reduction in overall morbidity and 

mortality among individual tobacco 

users; 

• Testing of actual consumer 

perception shows that, as the applicant 

proposes to label and market the 

product, consumers will not be misled 

into believing that the product is or has 

been demonstrated to be less harmful, or 

presents or has been demonstrated to 

present less of a risk of disease than one 

or more other commercially marketed 

tobacco products; and 

• Issuance of the exposure 

modification order is expected to benefit 

the health of the population as a whole 

taking into account both users of 

tobacco products and persons who do 

not currently use tobacco products 

(section 911(g)(2)(B) of the FD&C Act). 

In evaluating the benefit to health of 

individuals and of the population as a 

whole under sections 911(g)(1) and 

(g)(2) of the FD&C Act, FDA must take 

into account: 

• The relative health risks the 

modified risk tobacco product presents 

to individuals; 

• The increased or decreased 

likelihood that existing tobacco product 

users who would otherwise stop using 

such products will switch to using the 

modified risk tobacco product; 

• The increased or decreased 

likelihood that persons who do not use 

tobacco products will start using the 

modified risk tobacco product; 

• The risks and benefits to persons 

from the use of the modified risk 

tobacco product compared to the use of 

smoking cessation drug or device 

products approved by FDA to treat 

nicotine dependence; and 

• Comments, data, and information 

submitted to FDA by interested persons 

(section 911(g)(4) of the FD&C Act). 

Furthermore, FDA must ensure that 

the advertising and labeling of the 

MRTP enable the public to comprehend 

the information concerning modified 

risk and to understand the relative 

significance of such information in the 

context of total health and in relation to 

all of the tobacco-related diseases and 

health conditions (section 911(h)(1) of 

the FD&C Act). 

FDA intends to determine whether it 

will issue an order under section 911(g) 

within 360 days after the receipt of a 

complete application and will issue 

such an order only if the application 

satisfies all the applicable requirements 

in section 911. 

A risk modification order issued 

under section 911(g)(1) will be effective 

for the period of time specified in the 

order issued by FDA (section 911(h)(4) 

of the FD&C Act). An applicant to whom 

a risk modification order is issued under 

section 911(g)(1) must conduct 

postmarket surveillance and studies 

(section 911(i)(1) of the FD&C Act). 

An exposure modification order 

issued under section 911(g)(2) will be 

effective for a term of not more than 5 

years. FDA may renew an exposure 

modification order if the applicant files 

a new application, and FDA finds that 

the requirements for such order under 

section 911(g)(2) continue to be satisfied 

(section 911(g)(2)(C)(i) of the FD&C Act). 

Further, an exposure modification order 

will be conditioned on the applicant’s 

agreement to conduct postmarket 

surveillance and studies and to submit 

the results of such surveillance and 

studies to FDA annually (section 

911(g)(2)(C)(ii) and (iii) of the FD&C 

Act). 

The postmarket surveillance and 

studies that all applicants who receive 

orders are required to conduct are 

intended to determine the effect of 

issuance of an order on consumer 

perception, behavior, and health, and 

enable FDA to review the accuracy of 

the determinations upon which an order 

was based (section 911(g)(2)(C)(ii) and 

(i)(1) of the FD&C Act). An applicant 

who receives a risk modification order 

must also conduct postmarket 

surveillance and studies that provide 

information FDA determines is 

otherwise necessary regarding the use or 

health risks involving the tobacco 

product (section 911(i)(1) of the FD&C 

Act). 

If the proposed modified risk tobacco 

product is a new tobacco product within 

the meaning of section 910(a)(1), the 

new tobacco product must satisfy any 

applicable premarket review 

requirements under section 910 of the 

FD&C Act, in addition to any 

requirements under section 911 of the 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20029 

FD&C Act. A new tobacco product must 

be found to be substantially equivalent, 

exempt from the requirement to obtain 

a substantial equivalence determination, 

or have a marketing authorization order 

under section 910(c)(1)(A)(i). The 

collections of information relating to 

premarket review described in the 

‘‘Guidance for Industry: Section 905(j) 

Reports: Demonstrating Substantial 

Evidence for Tobacco Products’’ (OMB 

control number 0910–0673), 21 CFR 

part 1107 (Establishment Registration, 

Product Listing, and Substantial 

Equivalence Reports) (OMB control 

number 0910–0684), and ‘‘Draft 

Guidance for Industry: Applications for 

Premarket Review of New Tobacco 

Products’’ (OMB control number 0910– 

NEW) have been previously approved, 

or are pending approval, by OMB. An 

applicant may file the appropriate 

report or application to satisfy any 

applicable premarket review 

requirements and a separate application 

under section 911. In the alternative, the 

applicant may file a single application. 

The single application must include the 

information required for the applicable 

premarket review (i.e., substantial 

equivalence report, request of 

exemption from substantial equivalence 

requirements, or the information 

required for premarket review under 

section 910(b) of the FD&C Act), as well 

as the information required to support 

issuance of an order under section 

911(g) of the FD&C Act. To the extent 

data or information contained in the 

premarket review portion of the 

application is also relevant to or 

required for the modified risk 

determination, the applicant may crossreference that data or information rather 

than duplicate it in the modified risk 

portion of the application. 

Description of respondents: The 

respondents to this collection of 

information are applicants who are 

responsible for creating and submitting 

modified risk tobacco product 

applications and who wish to obtain an 

FDA order to allow them to market their 

product. While it is expected that many 

of the respondents will be 

manufacturers, respondents could 

include importers, distributors, and 

retailers of tobacco products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collected (section(s)) Number of respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total annual 

hours 

MRTPA (911(d) of FD&C Act) ............................................. 3 1 3 45,200 135,600 

Environmental analysis (21 CFR 25.15) .............................. 3 1 3 10 30 

Request for a meeting prior to submitting a MRTPA .......... 8 1 8 8 64 

Submission of postmarket surveillance and study protocols 

(911(g)(2)(C)(ii) and 911(i)(2)) ......................................... 3 1 3 30 90 

Conduct of postmarket surveillance and studies 

(911(g)(2)(C)(ii) and 911(i)(1)) ......................................... 5 1 5 40,200 201,000 

Annual submission of results of postmarket surveillance 

and studies (911(g)(2)(C)(iii) and 911(i)(1)) ..................... 5 1 5 140 700 

Requests for renewal (911(g)(2)(C)(i) and 911(h)(4)) ......... 1 1 1 140 140 

Total Reporting Burden Hours ...................................... ........................ ........................ ........................ ........................ 337,624 

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

Table 1 describes the annual reporting 

burden as a result of submitting a 

MRTPA. FDA estimates that it will 

receive 3 MRTPAs annually and that it 

will take the applicant 200 hours to 

collect the information necessary to 

submit a MRTPA under section 911 of 

the FD&C Act. FDA estimates it will 

take the applicant an additional 45,000 

hours to conduct studies needed to 

support its MRTPA. FDA is also 

including an estimation of the burden 

associated with preparing 

environmental analyses. FDA estimates 

that it will take an additional 10 hours 

to prepare any environmental analyses. 

FDA encourages persons considering 

developing a MRTPA to meet with CTP 

to discuss MRTPA submission and 

investigational requirements. FDA 

anticipates that eight persons 

considering developing MRTPAs may 

request meetings with FDA. FDA 

estimates it will take 8 hours to prepare 

a meeting request, including 

background information. 

Section 911 of the FD&C Act requires 

applicants to whom FDA issues orders 

to conduct postmarket surveillance and 

studies and submit relevant information 

to FDA on an annual basis. Applicants 

must submit and receive FDA approval 

of surveillance protocols. FDA estimates 

that it will take 30 hours to collect and 

submit the protocol information to FDA. 

FDA estimates it will take the applicant 

an additional 40,200 hours to conduct 

the postmarket surveillance and studies. 

FDA estimates 5 applicants will submit 

results of postmarket surveillance and 

studies annually and it will take 140 

hours to prepare each submission. 

Because orders issued under section 

911(g) are valid for only a set number 

of years, FDA expects applicants will 

submit requests for renewal. Because 

the dates on which orders are issued 

and the length of the period for which 

the order is valid will vary, FDA expects 

one request for renewal annually. FDA 

estimates that it will take 140 hours to 

prepare the request for renewal. 

The total number of hours for this 

collection of information is estimated to 

be 337,624 ((3 × (45,200 + 10)) + (8 × 

8) + (3 × 30) + (5 × 40,200) + (5 × 140) 

+ (1 × 140)). These burden estimates 

were computed using FDA staff 

expertise and by reviewing comments 

received from recent FDA information 

collections for other tobacco-related 

initiatives. 

IV. Request for Comments 

FDA requests comments from 

interested parties on any of the topics 

addressed in the draft guidance. In 

addition, as stated in the ‘‘I. 

Background’’ section, FDA intends to 

consider the IOM report in preparing 

the final guidance. Therefore, FDA 

requests comments from interested 

parties on the IOM report, which was 

issued on December 14, 2011. FDA 

specifically requests comments on: 

• IOM’s Recommendation 2: ‘‘The 

FDA should establish guidance that 

conveys an expected sequencing of 

studies, such that preclinical work is 

mstockstill on DSK4VPTVN1PROD with NOTICES

20030 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

completed and submitted to the FDA 

before clinical (human subjects) work 

commences, and [FDA should establish] 

that there is a reasonable expectation 

based on preclinical work that a 

reduction or lack of harm will be seen 

in humans.’’ Should FDA address 

expected sequencing of studies in its 

guidance? If the Agency should, what 

guidance should the Agency provide?; 

and 

• IOM’s Recommendation 10: ‘‘MRTP 

sponsors should consider use of 

independent third parties to undertake 

one or more key functions, including 

the design and conduct of research, the 

oversight of specific studies, and the 

distribution of sponsor funds for 

research. Such independent third 

parties should be approved by the FDA 

in advance of the research.’’ Should 

FDA recommend such an approach in 

its guidance? If the Agency should, what 

guidance should the Agency provide? 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain an electronic version of the 

draft guidance document at http:// 

www.regulations.gov and http:// 

www.fda.gov/TobaccoProducts/

GuidanceCompliance

RegulatoryInformation/default.htm. 

Dated: March 28, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7908 Filed 3–30–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0049] 

Draft Guidance for Industry: Reporting 

Harmful and Potentially Harmful 

Constituents in Tobacco Products and 

Tobacco Smoke Under the Federal 

Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Reporting Harmful 

and Potentially Harmful Constituents in 

Tobacco Products and Tobacco Smoke 

Under Section 904(a)(3) of the Federal 

Food, Drug, and Cosmetic Act.’’ The 

purpose of this draft guidance is to 

assist persons reporting to FDA the 

quantities of harmful and potentially 

harmful constituents (HPHCs) in 

tobacco products and tobacco smoke 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act). The draft 

guidance explains that FDA does not 

intend, at this time, to enforce reporting 

on the entire established HPHC list 

where a manufacturer or importer 

completes testing and reporting for an 

abbreviated list of HPHCs within the 

timeframes specified in the guidance. 

DATES: Although you can comment on 

any guidance at any time (21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 4, 2012. 

Submit either electronic or written 

comments on the proposed collection of 

information by June 4, 2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document to the Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

a fax number to which the draft 

guidance may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance, including comments on 

the proposed collection of information 

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. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: James 

Flahive, Center for Tobacco Products, 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850– 

3229, 1–877–287–1373, 

james.flahive@fda.hhs.gov. 

With regard to the proposed 

collection of information: Daniel 

Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, daniel.gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (the Tobacco 

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

The Tobacco Control Act amends the 

FD&C Act and grants FDA authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect public health generally and to 

reduce tobacco use by minors. Section 

904(a)(3) of the FD&C Act (21 U.S.C. 

387d(a)(3)) requires each tobacco 

product manufacturer or importer, or an 

agent, to begin reporting to FDA no later 

than June 22, 2012, ‘‘all constituents, 

including smoke constituents, identified 

by [FDA] as harmful or potentially 

harmful to health in each tobacco 

product, and as applicable in the smoke 

of each tobacco product.’’ Reports must 

be by the brand and by quantity in each 

brand and subbrand. Section 904(c)(1) 

states that manufacturers of tobacco 

products not on the market as of June 

22, 2009, must also provide information 

reportable under section 904(a)(3) at 

least 90 days prior to introducing the 

product into interstate commerce. 

FDA has taken several steps to 

identify HPHCs to be reported under 

section 904(a)(3), including issuing a 

final guidance discussing FDA’s current 

thinking on the meaning of ‘‘harmful 

and potentially harmful constituent’’ in 

the context of implementing the HPHC 

list requirement (76 FR 5387, January 

31, 2011). The guidance is available on 

the Internet at http://www.fda.gov/ 

TobaccoProducts/

GuidanceComplianceRegulatory

Information/ucm241339.htm. In 

addition, on August 12, 2011, FDA 

issued a document (the HPHC notice; 76 

FR 50226) in the Federal Register 

describing the criteria we tentatively 

concluded we would use in identifying 

the HPHCs for the established list, 

including a table of the 96 HPHCs we 

identified using those criteria, and 

asking the public and interested parties 

to submit relevant scientific and other 

information by October 11, 2011. FDA 

reviewed comments received in 

response to the HPHC notice. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a notice announcing 

the established list of HPHCs as 

required by section 904(e) of the FD&C 

Act. 

This draft guidance discusses the 

information to be reported on HPHCs in 

tobacco products and tobacco smoke 

under section 904(a)(3) of the FD&C Act. 

This draft guidance document 

discusses, among other things: The 

statutory requirement for testing and 

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