Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Information Request Regarding Dissolvable Tobacco Products, 11485-11487 [2011-4613]

Download as PDF Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 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 https://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) [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 Food and Drug Administration, HHS. ACTION: Notice. 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 emcdonald on DSK2BSOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Information Request Regarding Dissolvable Tobacco Products—(OMB Control Number 0910–NEW) Dated: February 24, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. AGENCY: Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.Capezzuto@fda.hhs.gov. 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; PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 11485 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 E:\FR\FM\02MRN1.SGM 02MRN1 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 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: 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 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Annual frequency per response Number of respondents Activity Total annual responses Hours per response Total hours Total capital costs Submission of Dissolvable Tobacco Product Documents Under Section 904(b) Total .................................................. emcdonald on DSK2BSOYB1PROD with NOTICES Large Tobacco Manufacturers or Importers ......................................................... Small to Medium Tobacco Product Manufacturers or Importers ......................... Submission of Letter indicating no documents available .................................... 3 VerDate Mar<15>2010 17:12 Mar 01, 2011 Jkt 223001 3 7,500 22,500 $435 7 1 7 230 1,610 324 110 1 110 1 110 165 120 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 1 ........................ 120 ........................ 24,220 924 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 E:\FR\FM\02MRN1.SGM 02MRN1 emcdonald on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 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 VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 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. 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 SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 11487 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 E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11485-11487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4613]


-----------------------------------------------------------------------

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

[[Page 11486]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Annual
                        Activity                             Number of     frequency per   Total annual      Hours per      Total hours    Total capital
                                                            respondents      response        responses       response                          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                       7               1               7             230           1,610             324
 Importers..............................................
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

[[Page 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 x [$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 x [$20 + $8]). The 
remaining two manufacturers will submit their documents via paper, 
which is estimated to cost $184 (2 manufacturers x [$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 x [$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

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