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draft guidance document at http:// 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Draft Guidance for Industry: Reporting 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availability of a draft guidance for 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purpose of this draft guidance is to 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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Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20031 

reporting quantities of HPHCs, who tests 

and reports quantities of HPHCs to FDA, 

what HPHCs will be the focus of FDA 

enforcement at this time, when reports 

are submitted to FDA, what information 

is reported to FDA, and how the reports 

should be submitted to FDA. The draft 

guidance notifies manufacturers and 

importers that at this time, while 

industry is developing laboratory 

capacity to comply with section 

904(a)(3), FDA does not intend to 

enforce the statutory requirement to 

submit quantities of all constituents 

identified by FDA as HPHCs by June 22, 

2012, where manufacturers or importers 

complete testing and reporting for an 

abbreviated list of HPHCs as set forth in 

the draft guidance. In particular, at this 

time, for products that were first 

marketed before June 22, 2012, FDA 

does not intend to enforce the section 

904(a)(3) requirement to test and report 

quantities of all HPHCs on FDA’s 

established list where: (1) A 

manufacturer or importer (or agents 

thereof), other than a small tobacco 

product manufacturer, submits 

quantities of the HPHCs on an 

abbreviated list described in the draft 

guidance for all of its products, by brand 

and subbrand, no later than September 

22, 2012; or (2) a small tobacco product 

manufacturer (or agents thereof) submits 

quantities of HPHCS on the abbreviated 

list for all of its products, by brand and 

subbrand, by December 22, 2012. In 

addition, for products first marketed on 

or after June 22, 2012, the draft guidance 

explains that FDA does not intend, at 

this time, to enforce the requirement in 

section 904(c)(1) to test and report 

quantities of all HPHCs on FDA’s 

established list for products not 

previously on the market if a 

manufacturer or importer reports 

quantities for the abbreviated list of 

HPHCs at least 90 days prior to 

marketing the product in the United 

States. In addition, the draft guidance 

explains that at this time, FDA intends 

to enforce the HPHC reporting 

requirements with respect to 

manufacturers of finished tobacco 

products for consumer use—cigarettes, 

smokeless tobacco, and roll-your-own 

tobacco—and not with respect to 

manufacturers and importers of other 

products, such as components sold to 

manufacturers or consumers for 

incorporation into finished products. 

Although this draft guidance 

announces an intent to exercise 

enforcement discretion for a limited 

time, FDA intends to move toward full 

implementation and enforcement of the 

statutory requirement to test and report 

quantities of all HPHCs on FDA’s 

established list, as appropriate. We 

anticipate that this guidance will be 

revised or withdrawn as we move 

toward full implementation. We intend 

to use the information submitted under 

sections 904(a)(3) and 904(c)(1) of the 

FD&C Act to meet the requirements of 

section 904(e) of the FD&C Act 

regarding a list of HPHCs in each 

tobacco product by brand and by 

quantity in each brand and subbrand. 

Also, the information will be used to 

comply with section 904(d)(1) of the 

FD&C Act, which requires FDA to 

publish a list of HPHCs, by brand and 

by quantity in each brand and subbrand, 

in a format that is understandable and 

not misleading to lay persons. 

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 reporting HPHCs in 

tobacco products and tobacco smoke 

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

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 a notice 

of the proposed collection of 

information set forth in the 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.’’ 

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: 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 (OMB Control Number 0910–NEW) 

The purpose of the proposed 

information collection is to allow FDA 

to collect statutorily mandated 

information regarding HPHCs in tobacco 

products and tobacco smoke, by brand 

and by quantity in each brand and 

subbrand. The draft guidance provides 

an abbreviated list of HPHCs on which 

FDA intends to focus enforcement at 

this time for each of the following: 

Cigarette smoke, smokeless tobacco 

products, and roll-your-own tobacco 

and cigarette filler. 

To facilitate the submission of HPHC 

information, FDA has developed forms 

in both paper and electronic formats. 

Manufacturers or importers, or an agent, 

may submit information either 

electronically or in paper format. The 

FDA eSubmitter tool provides electronic 

forms to streamline the data entry and 

submission process for reporting 

HPHCs. Users of eSubmitter may also 

populate an Excel file and import data 

into eSubmitter. FDA also provides 

paper forms for the submission of 

section 904(a)(3) reports. FDA intends to 

place draft copies of the paper forms 

and screen shots of the electronic form 

and spreadsheet in this docket. 

Whether respondents decide to 

submit reports electronically or on 

paper, each form provides instructions 

for filling out and submitting HPHC 

information to FDA. The forms contain 

fields for company information, product 

information, and HPHC information. 

The draft guidance provides an 

abbreviated list of HPHCs on which 

FDA intends to focus enforcement at 

this time, and information to assist in 

the testing and reporting of HPHCs for 

cigarette smoke and filler, smokeless 

tobacco, and roll-your-own tobacco. 

FDA has created forms to assist in the 

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20032 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

reporting of HPHC information for each 

of these product types. 

Description of Respondents: The 

respondents to this collection of 

information include manufacturers or 

importers who complete testing and 

reporting for HPHCs in tobacco products 

and tobacco smoke under section 

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

could also include agents of 

manufacturers or importers who 

complete HPHC testing and reporting. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collected Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

Part 1—Section 904(a)(3) of the FD&C Act (Annualized Estimate of One-time Reporting) 2

1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms 

Cigarette ..................................................................... 120 10 .10 1,212 2 2,424 

Roll-Your-Own ............................................................ 46 3 .22 148 2 296 

Smokeless .................................................................. 200 1 .44 288 2 576 

Total ..................................................................... ........................ .......................... ........................ ........................ 3,296 

2. Testing of HPHC Quantities in Products 

Cigarette Filler ............................................................ 120 10 .1 1,212 9.42 11,417 

Roll-Your-Own ............................................................ 46 3 .22 148 9.42 1,394 

Smokeless .................................................................. 200 1 .44 288 12.06 3,473 

Total ..................................................................... ........................ .......................... ........................ ........................ 16,284 

3. Testing of HPHC Quantities in Mainstream Smoke 

Cigarette: International Organization for Standardization (ISO) Regimen ................................................. 120 10 .1 1,212 23.64 28,652 

Cigarette: Health Canada Regimen ........................... 120 10 .1 1,212 23.64 28,652 

Total ..................................................................... ........................ .......................... ........................ ........................ 57,304 

Total Section 904(a)(3) Annualized One-Time 

Burden .............................................................. ........................ .......................... ........................ ........................ 76,884 

Part 2—Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) 3

1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms 

Cigarette ..................................................................... 18 10 .10 182 2 364 

Roll-Your-Own ............................................................ 7 3 .22 23 2 46 

Smokeless .................................................................. 30 1 .44 43 2 86 

Total ..................................................................... ........................ .......................... ........................ ........................ 496 

2. Reporting of HPHC Quantities in Products 

Cigarette Filler ............................................................ 18 10 .1 182 9.42 1,714 

Roll-Your-Own ............................................................ 7 3 .22 23 9.42 217 

Smokeless .................................................................. 30 1 .44 43 12.06 519 

Total ..................................................................... ........................ .......................... ........................ ........................ 2,450 

3. Reporting of HPHC Quantities in Mainstream Smoke 

Cigarette: ISO Regimen ............................................. 18 10 .1 182 23.64 4,302 

Cigarette: Health Canada Regimen ........................... 18 10 .1 182 23.64 4,302 

Total ..................................................................... ........................ .......................... ........................ ........................ 8,604 

Total Section 904(c)(1) Burden ........................... ........................ .......................... ........................ ........................ 11,550 

Total Reporting Burden Hours ............................ ........................ .......................... ........................ ........................ 88,434 

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

2One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid overcounting the burden 

each year. 3Annual new product reporting under section 904(c)(1) is estimated to be 15% of the annualized one-time burden. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 20033 

FDA estimates the one-time reporting 

burden for this guidance would be 

230,652 hours during the first year for 

section 904(a)(3) reporting plus ongoing 

annual burden of 11,550 hours for 

section 904(c)(1) reporting. The burden 

estimate for this collection of 

information includes the time it will 

take to read the guidance document, test 

the products, and prepare the HPHC 

report. 

To avoid overcounting the one-time 

reporting burden, FDA has divided the 

first year burden by three, annualizing 

the one-time burden over the 3-year 

expected OMB period of approval to 

avoid double-counting the one-time 

projected burden. The one-time burden 

for year one is located in part 1 of table 

1 of this document, and includes burden 

for collections of information gathered 

under section 904(a)(3). The annualized 

total one-time burden in part 1 of table 

1 is 76,884 hours (230,652 hours 

divided by 3), which includes 3,296 

hours for reporting manufacturer or 

importer company and product 

information, 16,284 hours for reporting 

HPHC quantities in products, and 

57,304 hours for reporting HPHC 

quantities in mainstream smoke. 

As shown in table 1, the total annual 

burden for this collection of information 

is estimated to be 88,434 hours, which 

is the annualized one-time burden 

estimate for section 904(a)(3) associated 

with the submission of an HPHC (76,884 

hours) and the annual burden estimate 

for section 904(c)(1) (11,550 hours). We 

have assumed a one-time burden for 

section 904(a)(3) because this draft 

guidance is intended to remain in effect 

while industry is developing laboratory 

capacity to comply fully with section 

904(a)(3) of the FD&C Act. We also 

assume any new product reporting 

requirements under section 904(c)(1) 

will be provided annually to FDA. We 

also anticipate this guidance will be 

revised or withdrawn as FDA moves 

toward full implementation and 

enforcement of the statutory 

requirement to report quantities by 

brand and subbrand of all HPHCs on 

FDA’s established HPHC list. 

Part one of table 1 estimates that 366 

respondents (120 cigarette 

manufacturers or importers, 200 

smokeless manufacturers, and 46 rollyour-own tobacco manufacturers) will 

submit 4,942 HPHC reports on a onetime basis (e.g., 1,648 reports on an 

annualized basis). As noted previously, 

FDA estimates that it will take the 

manufacturer, importer, or their agents 

230,652 hours on a one time basis, or 

76,884 hours annually, to collect the 

information necessary to test the 

products and submit an HPHC report by 

brand and subbrand. 

Part one, section one of table 1 

addresses the time required for 

manufacturers and importers to report 

their company information: Company 

name; mailing address; telephone and 

FAX numbers; FDA Establishment 

Identifier (FEI) number; Data Universal 

Numbering System (D–U–N–S) number; 

and point of contact name, mailing 

address, and telephone and FAX 

numbers. The first section of table 1 also 

addresses the time required for 

manufacturers and importers to report 

their product information by entering 

testing information onto the forms: 

Brand and subbrand name; unique 

product identification number; type of 

product identification number; product 

category and subcategory; and mean 

weight and standard deviation of 

tobacco in product. We estimate that the 

burden is no more than 2 hours per 

response to report company and product 

information testing regardless of 

whether the paper or electronic form 

(Form FDA 3787) is used. This estimate 

is not dependent on product type, so the 

estimated burden is the same for 

cigarettes, roll-your-own tobacco, and 

smokeless tobacco products. We 

estimate that there are 3,636 cigarette 

subbrands, 445 roll-your-own tobacco 

subbrands, and 861 smokeless tobacco 

subbrands (4,942 total subbrands) that 

must comply with section 904(a)(3) of 

the FD&C Act. Therefore, the total 

annualized burden for reporting 

company and product information is 

3,296 hours (4,942 respondents × 2 

hours = 9,884 one-time hours divided 

by 3). 

Part one, section two of table 1 

addresses the time required from 

manufacturers and importers to report 

quantities for HPHCs in their products: 

Number of replicate measurements; test 

date range; manufacture date range; 

extraction method; separation method; 

detection method; and mean quantity 

and standard deviation of HPHCs. The 

burden hour estimates in this section 

include the time needed to test the 

tobacco products, draft testing reports, 

draft the report for FDA, and submit the 

report to FDA. For cigarette filler, 

smokeless, and roll your own products, 

we estimate the burden to draft testing 

reports, draft the report for FDA, and 

submit the report to FDA to be 48,852 

one-time hours, or 16,284 annualized 

burden hours. The burden for each 

product type reflects our estimate of the 

burden to test the tobacco products (i.e., 

carry out laboratory work). The perresponse burden for testing cigarette 

filler and roll-your-own tobacco is the 

same, as the same HPHCs must be 

measured for both product types. The 

per-response burden for testing 

smokeless products is greater than that 

for the other two product types because 

more HPHCs must be tested for 

smokeless products than the other two 

product types. 

Part one, section three of table 1 

addresses the time required for 

manufacturers and importers to report 

quantities for HPHCs in cigarette smoke: 

The number of replicate measurements; 

test date range; manufacture date range; 

extraction method; separation method; 

detection method; and mean quantity 

and standard deviation of HPHCs. The 

burden estimates include the burden to 

test the tobacco products, draft testing 

reports, draft the report for FDA, and 

submit the report to FDA. We estimate 

the one-time burden for this section to 

be 171,912 hours, or 57,304 annualized 

hours. The annualized burden reflects 

our estimate of the burden to test the 

tobacco products (i.e., carry out 

laboratory work). The burden estimate 

assumes that manufacturers and 

importers report HPHC quantities in 

cigarette mainstream smoke according 

to the two recommended smoking 

regimens. The total annualized burden 

for part one of table 1 (section 904(a)(3) 

reporting) is 76,884 hours (3,296 hours 

plus 16,284 hours plus 57,304 hours). 

Part two of table 1 contains estimates 

for new product information received 

under section 904(c)(1). Manufacturers 

and importers must report HPHC 

information under section 904(c)(1) at 

least 90 days prior to delivery for 

introduction into interstate commerce. 

We estimate that approximately 15 

percent of FDA currently regulated 

tobacco products in any given year will 

require submission of this information. 

The estimated total annual burden for 

section 904(c)(1) is 11,550 hours, which 

includes 496 hours to report 

manufacturer/importer company and 

product information, 2,450 hours to 

report HPHC quantities in products, and 

8,604 hours to report HPHC quantities 

in mainstream smoke. 

The estimated total annual burden for 

the reporting of HPHC under sections 

904(a)(3) and 904(c)(1) is 88,434 hours 

(76,884 annualized burden hours for 

section 904(a)(3) reporting plus 11,550 

annual burden hours for section 

904(c)(1) reporting). 

We have not estimated any capital 

costs because we do not believe there 

are any capital costs associated with this 

collection. However, you may comment 

on any specific capital costs that you 

have identified. 

mstockstill on DSK4VPTVN1PROD with NOTICES

20034 Federal Register / Vol. 77, No. 64 / Tuesday, April 3, 2012 / Notices 

1 Information about TPSAC as well as information 

and background materials on TPSAC meetings are 

available at http://www.fda.gov/ 

AdvisoryCommittees/CommitteesMeetingMaterials/ 

TobaccoProductsScientificAdvisoryCommittee/

default.htm. 

2See 75 FR 22147 (April 27, 2010) and 75 FR 

33814 (June 15, 2010). Information submitted to the 

public docket for each of these meetings is available 

at http://www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/TobaccoProducts

ScientificAdvisoryCommittee/ucm222977.htm and 

http://www.fda.gov/AdvisoryCommittees/

CommitteesMeetingMaterials/TobaccoProducts

ScientificAdvisoryCommittee/ucm222978.htm. 

IV. 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 

documents 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 this 

guidance document at http://www.

regulations.gov and http://www.fda.gov/ 

TobaccoProducts/GuidanceC

omplianceRegulatoryInformation/

default.htm. 

Dated: March 23, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–7766 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–N–0143] 

Harmful and Potentially Harmful 

Constituents in Tobacco Products and 

Tobacco Smoke; Established List 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a list. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing a 

list of harmful and potentially harmful 

constituents (HPHCs) in tobacco 

products and tobacco smoke (the 

established HPHC list) as required by 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). 

FOR FURTHER INFORMATION CONTACT: 

Carol Drew, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

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

The Tobacco Control Act amended the 

FD&C Act (21 U.S.C. 301 et seq.) by, 

among other things, adding a new 

chapter granting FDA important new 

authority to regulate the manufacture, 

marketing, and distribution of tobacco 

products to protect the public health. 

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

U.S.C. 387d(e)), as added by the 

Tobacco Control Act, requires FDA to 

establish, and periodically revise as 

appropriate, ‘‘a list of harmful and 

potentially harmful constituents, 

including smoke constituents, to health 

in each tobacco product by brand and 

by quantity in each brand and 

subbrand.’’ 

The Agency has considered comments 

solicited from the public, as well as 

scientific and other information, and 

has developed a list of tobacco product 

constituents it currently believes are 

harmful or potentially harmful to 

health. We are establishing this list as 

table 1 of this document as required by 

section 904(e) of the FD&C Act. In this 

document, we are also providing 

information about related actions, 

including the Agency’s guidance 

discussing the meaning of HPHC, the 

criteria the Agency used to help develop 

the established HPHC list, the reasons 

the Agency may add or remove 

constituents from the established HPHC 

list consistent with the directive of 

section 904(e), and the addition of 

quantities to the list. 

II. Background 

On January 31, 2011, FDA announced 

the availability of a guidance entitled 

‘‘ ‘Harmful and Potentially Harmful 

Constituents’ in Tobacco Products as 

Used in Section 904(e) of the Federal 

Food, Drug, and Cosmetic Act’’ (76 FR 

5387) (available at www.fda.gov/

TobaccoProducts/GuidanceCompliance

RegulatoryInformation) (HPHC final 

guidance). This guidance represents the 

Agency’s current thinking on the 

meaning of the term ‘‘harmful and 

potentially harmful constituent’’ in the 

context of implementing section 904(e) 

of the FD&C Act. It states: ‘‘FDA 

believes that the phrase ‘harmful and 

potentially harmful constituent’ 

includes any chemical or chemical 

compound in a tobacco product or in 

tobacco smoke: (a) That is or potentially 

is inhaled, ingested, or absorbed into the 

body; and (b) that causes or has the 

potential to cause direct or indirect 

harm to users or non-users of tobacco 

products’’ (HPHC final guidance at page 

2). The HPHC final guidance includes 

examples of constituents that have the 

potential to cause direct harm and 

examples of constituents that have the 

potential to cause indirect harm: 

‘‘Examples of constituents that have the 

‘potential to cause direct harm’ to users 

or non-users of tobacco products 

include constituents that are toxicants, 

carcinogens, and addictive chemicals 

and chemical compounds. Examples of 

constituents that have the ‘potential to 

cause indirect harm’ to users or nonusers of tobacco products include 

constituents that may increase the 

exposure to the harmful effects of a 

tobacco product constituent by: (1) 

Potentially facilitating initiation of the 

use of tobacco products; (2) potentially 

impeding cessation of the use of tobacco 

products; or (3) potentially increasing 

the intensity of tobacco product use 

(e.g., frequency of use, amount 

consumed, depth of inhalation). 

Another example of a constituent that 

has the ‘potential to cause indirect 

harm’ is a constituent that may enhance 

the harmful effects of a tobacco product 

constituent’’ (HPHC final guidance at 

page 2). 

On May 1, 2010, a subcommittee of 

the Tobacco Products Scientific 

Advisory Committee (TPSAC),1 the 

Tobacco Product Constituents 

Subcommittee (the subcommittee), was 

established and charged with making 

preliminary recommendations to 

TPSAC on the HPHCs in tobacco 

products and tobacco smoke. The 

subcommittee held public meetings on 

June 8 and 9, 2010, and July 7, 2010. 

Prior to these meetings, FDA solicited 

data, information, and/or views on 

HPHCs in tobacco products and tobacco 

smoke from the public.2 At these 

meetings the subcommittee: 

• Reviewed example lists of HPHCs 

in tobacco products and tobacco smoke 

developed by other countries and 

organizations; 

• Identified criteria for selecting 

carcinogens, toxicants, and addictive 

chemicals or chemical compounds in 

tobacco products and tobacco smoke; 

• Identified chemicals or chemical 

compounds that met the identified 

criteria; 

• Confirmed the existence of methods 

for measuring each chemical or 

chemical compound identified; and 

• Identified other potentially 

important information or criteria for 

measuring HPHCs in tobacco products 

or tobacco smoke, such as smoking 

machine regimens to be used in 

measuring HPHCs. 

mstockstill on DSK4VPTVN1PROD with NOTICES