Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 11485 

the FOR FURTHER INFORMATION CONTACT

section of this notice by the date listed 

in the DATES section of this notice. 

CCIIO is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.hhs.gov/CCIIO for 

procedures on public conduct during 

advisory committee meetings. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 24, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–4556 Filed 2–25–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0542] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Information 

Request Regarding Dissolvable 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by April 1, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Information Request Regarding 

Dissolvable Tobacco Products.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezzuto@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 

Dissolvable Tobacco Products—(OMB 

Control Number 0910–NEW) 

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 amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by adding a new chapter 

granting FDA important new 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 917 of the Tobacco Control 

Act (21 U.S.C. 387q) requires the 

Secretary of Health and Human Services 

(the Secretary) to establish a Tobacco 

Products Scientific Advisory Committee 

(TPSAC). Section 907(f) of the Tobacco 

Control Act (21 U.S.C. 387g(f)) requires 

the TPSAC to submit a report and 

recommendations to the Secretary on 

the impact of the use of dissolvable 

tobacco products on the public health, 

including such use among children. To 

ensure a comprehensive review of this 

issue, FDA is requesting tobacco 

industry documents and information to 

support the work of TPSAC. Under 

section 907(f), TPSAC must submit its 

report and recommendations to the 

Secretary within 2 years after its 

establishment, or March 22, 2012. 

In order to provide TPSAC with the 

information it needs to carry out its 

statutory obligation, FDA is requesting 

that tobacco companies submit 

information under section 904(b) of the 

Tobacco Control Act (21 U.S.C. 387d(b)) 

pertaining to documents and underlying 

scientific and financial information 

relating to research, and research 

findings, conducted, supported, or 

possessed by the manufacturer (or 

agents thereof) on a specified set of 

topics. For the purposes of this request, 

‘‘research’’ may include, but is not 

limited to, focus groups, surveys, 

experimental clinical studies, 

postmarketing surveillance, 

toxicological and biochemical assays, 

taste panels, and assessments of the 

effectiveness of product marketing 

practices. Topics for which information 

relating to dissolvable tobacco products 

is requested are marketing research; 

marketing practices; effectiveness of 

marketing practices; and health, 

toxicological, behavioral, and 

physiological effects. FDA’s request for 

documents related to dissolvable 

tobacco products includes, but is not 

limited to products for research, 

investigational use, developmental 

studies, test marketing, and/or 

commercial marketing, and also to the 

components, parts, or accessories of 

such products. 

In the Federal Register of October 25, 

2010 (75 FR 65490), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received eight 

comments from seven commenters; six 

comments pertaining to the notice, and 

two comments pertaining to the 

information collection. Six comments 

were beyond the scope of this 

information request (e.g., tobacco is 

dangerous, dissolvable tobacco products 

are appealing to children, FDA should 

let the market prevail, FDA reviewers 

and TPSAC are not impartial). 

Comments relevant to the information 

request are addressed in this document. 

One commenter suggested that they 

would like to withhold proprietary 

information or have FDA mark the 

information received as ‘‘confidential 

and proprietary’’, and would like FDA to 

explicitly state in the letter that FDA 

does not require nor accept publically 

available information. The commenter 

would like FDA to accept submission of 

lists, summaries, and abstracts as a first 

pass so FDA could then decide which 

documents it really needs, and would 

like FDA to better explain what it is 

looking for with regard to internal 

reports. The commenter would like FDA 

to restrict submissions to primary 

research data, and would like FDA to 

provide specific instructions for the 

citing of previously submitted 

documents so they can be fully 

referenced. FDA’s response is that, with 

regard to confidential and proprietary 

information, documents submitted 

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

may include, but are not limited to a 

company’s non-public, trade secret, or 

confidential commercial information. 

FDA also notes that several laws govern 

maintaining the confidentiality of new 

tobacco product information submitted 

under section 904(b), including sections 

301(j) and 906(c) of the FD&C Act 

(21 U.S.C. 331(j) and 387f(c)), the Trade 

Secrets Act (18 U.S.C. 1905), and the 

Freedom of Information Act (FOIA) 

(5 U.S.C. 552), as well as FDA’s 

implementing regulations. FDA’s 

general regulations concerning the 

public availability of FDA’s records are 

contained in 21 CFR part 20. With 


emcdonald on DSK2BSOYB1PROD with NOTICES
11486 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 

regard to the submission of summary 

lists instead of documents, it is the 

responsibility of manufacturers and 

importers to identify and submit all 

documents that are responsive to a 

request under section 904(b). 

Information which could be responsive 

to this section 904(b) request that has 

been previously provided to FDA does 

not have to be re-submitted as long as 

the document is fully referenced with 

information including file name and file 

extension, Bates number (begin Bates 

number to end Bates number), the date 

of submission, and relevant page 

numbers. If the documents were 

previously submitted to FDA under the 

section 904(a)(1), 904(c)(1), 904(c)(2) or 

904(c)(3) requirement to submit listings 

of ingredients in tobacco products, FDA 

asks that the respondent please provide 

the date of submission, section under 

which the document was submitted, 

and the tobacco product brand/ 

subbrand name and product 

identification number. 

One commenter indicated that they 

bear responsibility for coordinating the 

implementation of the Tobacco Control 

Act for itself and its subsidiaries, and 

that they had already provided FDA 

with substantial information regarding 

dissolvable tobacco products in 

response to a February 1, 2010, request 

from FDA for this information. They 

also are concerned that FDA does not 

appear to give meaningful consideration 

to the burden imposed by FDA’s 

requests, or to respondent’s ideas for 

more efficient collections of 

information. The commenter hoped that 

FDA will consider the comments 

received as it continues to formulate 

future document and information 

collection requests and realize that FDA 

has seriously underestimated the time 

and cost burden to gather, review, and 

produce the requested documents. In 

addition, the commenter felt that FDA 

did not adequately explain how it 

calculated the estimated burden for 

respondents, as the 230 burden hours 

listed in the 60-day Federal Register 

notice may be accurate for 

manufacturers conducting peripheral 

research, but may not be that accurate 

for a large tobacco manufacturer. The 

commenter stated that they estimate it 

will take 10,000 hours to produce the 

documents FDA requested related to 

dissolvable tobacco products. The 

commenter stated that FDA has 

exhibited a pattern of underestimating 

burden associated with document 

production requests in the past, and that 

this collection runs counter to the PRA 

because the collection does not 

minimize respondent burden, and will 

have no practical utility to FDA. The 

commenter also asked that FDA, rather 

than respondents, identify previously 

submitted documents because they 

should be able to produce this 

information using commonly available 

commercial software. The commenter 

re-emphasized that FDA and TPSAC 

would be unable to process the sheer 

volume of this information, so it has 

little practical utility and does not 

minimize paperwork burden in 

violation of the PRA. They ask that FDA 

revise its estimated time and burden on 

manufacturers, allow time for 

meaningful review, and maximize the 

practical utility of this collection. In 

estimating the initial burden for this 

collection, FDA utilized its staff 

expertise and previous experience with 

similar types of Agency collections to 

determine the burden. While FDA 

understands that there appears to be a 

large discrepancy in burden between 

this commenter’s estimate and FDA’s 

estimate, FDA did follow a methodology 

to determine as accurate an estimate of 

average burden as possible. However, 

due to the comments received for this 

information collection and other 

comments submitted by stakeholders, 

FDA has revised the burden for this 

collection. Information received by the 

public directly and in response to 

requests for comments will assist FDA 

in determining more accurate burden 

estimates in the future. With regard to 

the submission of documents 

previously, it is the responsibility of 

manufacturers and importers to identify 

and submit all documents that are 

responsive to a request under section 

904(b). As stated in the 60-day Federal 

Register notice (75 FR 65490) and letter, 

information responsive to this section 

904(b) request which has been 

previously submitted to FDA under the 

Tobacco Control Act does not have to be 

re-submitted as long as the document is 

fully referenced. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Activity Number of 

respondents 

Annual 

frequency 

per response 

Total 

annual 

responses 

Hours per 

response Total hours Total capital costs 

Submission of Dissolvable Tobacco Product Documents Under Section 904(b) 

Large Tobacco Manufacturers or Importers ......................................................... 3 1 3 7,500 22,500 $435 

Small to Medium Tobacco Product Manufacturers or Importers ......................... 7 1 7 230 1,610 324 

Submission of Letter indicating no documents available .................................... 110 1 110 1 110 165 

Total .................................................. 120 ........................ 120 ........................ 24,220 924 

FDA has adjusted the burden for this 

information collection based on 

stakeholder and public comments 

received for this collection of 

information. Originally, FDA estimated 

that 10 tobacco manufacturers would be 

responsible for submitting documents, 

and that their burden would average 230 

hours each. After reviewing comments, 

FDA still maintains that 10 tobacco 

manufacturers will be responsible for 

submitting documents, and has now 

broken the burden into three tiers—large 

manufacturers and importers, small to 

medium manufacturers and importers, 

and manufacturers who are only 

required to submit a letter indicating 

that they have no tobacco documents to 

submit. As shown in table 1, FDA now 

estimates that 3 large manufacturers are 

estimated to take approximately 7,500 

hours apiece to provide dissolvable 

tobacco product documents, 7 small to 

medium manufactures are estimated to 

take approximately 230 hours apiece to 

provide dissolvable tobacco product 

documents, and 110 other 

manufacturers who do not have 

documents, do not manufacture 

dissolvable tobacco products, or do not 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 11487 

anticipate manufacturing dissolvable 

tobacco products will take 

approximately 1 hour to draft and send 

a letter to FDA indicating that they do 

not have documents to submit. These 

estimates were derived based upon FDA 

experience and feedback provided by 

public and stakeholder comments. 

The capital costs associated with this 

collection pertain to the postage for 

mailing documents in electronic or 

paper formats. Estimating these costs is 

problematic because the costs will vary 

depending on the size of the document 

production (e.g. one binder of 

documents vs. numerous boxes of 

paper) and the media type (e.g., compact 

disk (CD) or digital video disk) chosen 

to submit documents. Currently, we 

cannot identify how many documents 

will be submitted per response. 

Some sample postage costs are shown 

for different types of packages: 

• 10 CDs in a flat envelope weighing 

30 ounces: approximately $8.00 using 

first class business mail 

• 5-pound parcel containing paper 

documents: approximately $12 using 

business parcel post mail and delivering 

to the furthest delivery zone 

• 10-pound parcel containing paper 

documents: approximately $17 using 

business parcel mail and delivering to 

the furthest delivery zone 

• 50-pound parcel containing paper 

documents: approximately $52 using 

business parcel post mail and delivering 

to the furthest delivery zone. 

FDA estimates the capital costs 

associated with this document 

submission to be $924. The capital costs 

determined by this estimate are based 

upon 3 submissions for large 

manufacturers, 7 submissions for small 

to medium manufacturers, and 110 

submissions of 1 letter apiece for those 

who do not either manufacture 

dissolvable tobacco products or have 

documents pertaining to the 

manufacture of dissolvable tobacco 

products. 

For the three large manufacturers, it is 

estimated that each manufacturer will 

submit their documents electronically 

on the equivalent of one 500-gigabyte 

external hard drive of data. This is 

estimated to cost approximately $125 

per drive, and $20 to ship the drive, for 

a total of $435 (3 manufacturers × [$125 

+ $20]). 

For the 7 small to medium sized 

manufacturers, it is estimated that 5 

manufacturers (about 71 percent) will 

submit their documents electronically 

on the equivalent of 10 CD–ROMs. This 

is estimated to cost $20 for the 10 CD– 

ROM spindle, and $8 to ship each group 

of 10 CDs per envelope for a total of 

$140 (5 manufacturers × [$20 + $8]). The 

remaining two manufacturers will 

submit their documents via paper, 

which is estimated to cost $184 (2 

manufacturers × [$40 cost of one box of 

paper + $52 to ship the box of paper]). 

The total capital cost for small to 

medium manufacturers, therefore, is 

estimated to be $324 ($140 + $184). 

For the remaining 110 manufacturers 

who must submit a letter to FDA 

indicating that they do not have any 

documents, it is estimated that each 

manufacturer will use $1 of paper 

products and pay postage 

approximating a rounded figure of $0.50 

for a total of $165 (110 manufacturers × 

[$1.00 + $0.50]). Therefore, FDA 

estimates the total capital costs 

associated with this document 

submission to be $924. 

Dated: February 24, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–4613 Filed 3–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0201] 

Determination That NILSTAT (Nystatin 

Powder (Oral, 100%)) Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that NILSTAT (nystatin powder (oral, 

100%)) was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for nystatin 

powder (oral, 100%) if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer L. Stevens, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6316, 

Silver Spring, MD 20993–0002, 301– 

796–3602. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

NILSTAT (nystatin powder (oral, 

100%)) is the subject of NDA 050576, 

held by Dava Pharmaceuticals, Inc., and 

was initially approved on December 22, 

1983. NILSTAT is indicated for the 

treatment of intestinal and oral cavity 

infections caused by Candida (Monilia) 

albicans. NILSTAT (nystatin powder 

(oral, 100%)) is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Paddock Laboratories, Inc., submitted 

a citizen petition dated April 8, 2010 

(Docket No. FDA–2010–P–0201), under 

21 CFR 10.30, requesting that the 

Agency determine whether NILSTAT 

(nystatin powder (oral, 100%)) was 

withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

NILSTAT (nystatin powder (oral, 

100%)) was not withdrawn for reasons 

of safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that NILSTAT 

(nystatin powder (oral, 100%)) was 


emcdonald on DSK2BSOYB1PROD with NOTICES