Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products, 45937-45940 [2018-19664]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices Docket; Request for Comments.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, Fax: 301–847–8533, email: GIDAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 9, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 1, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 2, 2018. Persons attending FDA’s advisory committee meetings are advised that PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 45937 FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19670 Filed 9–10–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3031] Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for tobacco product user fees. SUMMARY: E:\FR\FM\11SEN1.SGM 11SEN1 45938 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices Submit either electronic or written comments on the collection of information by November 13, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 13, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: daltland on DSKBBV9HB2PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–N–3031 for ‘‘Tobacco Products, VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Under 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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products OMB Control Number 0910–0749— Extension 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 (FD&C Act) and granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. FDA issued a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the E:\FR\FM\11SEN1.SGM 11SEN1 45939 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices FD&C Act. FDA expanded its authority over tobacco products by issuing another final rule, ‘‘Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products’’ (Deeming rule), deeming all products that meet the statutory definition of ‘‘tobacco product,’’ except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act’s user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, the user fee final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. As noted, FDA issued a final rule that requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the FD&C Act. The U. S. Department of Agriculture (USDA) had been collecting this information and provided FDA with the data the Agency needed to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA ceased collecting this information in fiscal year 2015 (October 2014). USDA’s information collection did not require OMB approval, per an exemption by Public Law 108–357, section 642(b)(3). Consistent with the requirements of the FD&C Act, FDA requires the submission of this information to FDA now instead of USDA. FDA took this action to ensure that the Agency continues to have the information needed to calculate, assess, and collect user fees from domestic manufacturers and importers of tobacco products. Section 919(a) of the FD&C Act (21 U.S.C. 387s(a)) requires FDA to ‘‘assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products’’ subject to the tobacco product provisions of the FD&C Act (chapter IX of the FD&C Act). The total amount of user fees to be collected for each fiscal year is specified in section 919(b)(1) of the FD&C Act, and under section 919(a) FDA is to assess and collect a proportionate amount each quarter of the fiscal year. The FD&C Act provides for the total assessment to be allocated among the classes of tobacco products. The class allocation is based on each tobacco product class’ volume of tobacco product removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its share of the market for that tobacco product class. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 1150.5(a), (b)(1) and (2), and Form FDA 3852; General identifying information provided by manufacturers and importers of FDA regulated tobacco products and identification and removal information (monthly) ...................... 1150.5(b)(3); Certified copies (monthly) .............................. 1150.13; Submission of user fee information (Identifying information, fee amount, etc. (quarterly) .......................... 1150.15(a); Submission of user fee dispute (annually) ....... 1150.15(d); Submission of request for further review of dispute of user fee (annually) .......................................... Total .............................................................................. daltland on DSKBBV9HB2PROD with NOTICES 1 There Number of responses per respondent Number of respondents 21 CFR section Total annual responses Hours per response Total hours 658 658 12 12 7,896 7,896 3 1 23,688 7,896 329 5 4 1 1,316 5 1 10 1,316 50 3 1 3 10 30 ........................ ........................ ........................ ........................ 32,980 are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that 658 entities will submit tobacco product user fees. The entity count was derived from aggregate data provided by the Alcohol and Tobacco Tax and Trade Bureau (TTB), and reflects that in 2017 there were 192 total permitted manufacturers and 466 permitted importers over all tobacco product types for which TTB collects excise taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco, excluding electronic nicotine delivery systems). The estimate of 658 respondents to provide the information requested from § 1150.5(a), (b)(1) and (2) (21 CFR 1150.5(a), (b)(1) and (2)), and Form FDA 3852 reflects both reports of no removal of tobacco products into domestic commerce and reports of removal of tobacco product into domestic VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 commerce. FDA estimates it will take 3 hours for each of these submission types for a total of 23,688 hours. Under § 1150.5(b)(3), these respondents are also expected to provide monthly certified copies of the returns and forms that relate to the removal of tobacco products into domestic commerce and the payment of Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986 to FDA. We estimate that each monthly report will take 1 hour for a total of 7,896 hours. The estimate of 329 respondents to submit payment of user fee information under § 1150.13 reflects an average of half the number of domestic manufacturers and importers who may be subject to fees each fiscal quarter. FDA estimates the quarterly submission PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 will take approximately 1 hour for a total of 1,316 hours. FDA estimates that five of those respondents assessed user fees will dispute the amounts under § 1150.15(a), for a total amount of 50 hours. FDA also estimates that three respondents who dispute their user fees will ask for further review by FDA under § 1150.15(d), for a total amount of 30 hours. FDA has only received one dispute submission since fiscal year 2015. Based on this data, the Agency does not believe we will receive more than five disputes and three requests for further reviews in the next 3 years. FDA estimates the total annual burden for this collection of information is 32,980 hours. The estimated burden for the information collection reflects an overall increase of 16,058 hours. We E:\FR\FM\11SEN1.SGM 11SEN1 45940 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices attribute this adjustment to an increase in the number of entities submitting tobacco user fee information to FDA. Dated: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–19664 Filed 9–10–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3262] Determination That CEFZIL (Cefprozil) Tablets, 250 Milligrams and 500 Milligrams, and for Oral Suspension, 125 Milligrams/5 Milliliters and 250 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that CEFZIL (cefprozil) tablets, 250 milligrams (mg) and 500 mg and CEFZIL (cefprozil) for oral suspension, 125 mg/5 milliliters (mL) and 250 mg/5 mL were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) that refer to these drugs as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Diana J. Pomeranz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6288, Silver Spring, MD 20993–0002, 240– 402–4654. 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 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). daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:49 Sep 10, 2018 Jkt 244001 The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C 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 known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Under § 314.161(a)(2), the Agency must also determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness if ANDAs that referred to the listed drug have already been approved prior to its market withdrawal. If the Agency determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, and there are approved ANDAs that reference that listed drug, FDA will initiate a proceeding to determine whether the suspension of the ANDAs is also required (21 CFR 314.153(b)). CEFZIL (cefprozil) tablets, 250 mg and 500 mg, are the subject of NDA 050664 held by Corden Pharma Latina S.p.A., and initially approved on December 23, 1991. CEFZIL (cefprozil) for oral suspension, 125 mg/5 mL and 250 mg/ 5 mL, is the subject of NDA 050665 held by Corden Pharma Latina S.p.A., and initially approved on December 23, 1991. CEFZIL is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: • Upper respiratory tract: Pharyngitis/ tonsillitis caused by Streptococcus pyogenes; otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including blactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including b-lactamase-producing strains); and acute sinusitis caused by PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 Streptococcus pneumoniae, Haemophilus influenzae (including blactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including b-lactamase-producing strains); • Lower respiratory tract: Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including b-lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including b-lactamaseproducing strains); and • Skin and skin structure: Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including penicillinaseproducing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage. In a letter dated September 7, 2010, Bristol-Myers Squibb 1 notified FDA that CEFZIL (cefprozil) tablets, 250 mg and 500 mg and CEFZIL (cefprozil) for oral suspension, 125 mg/5 mL and 250 mg/ 5 mL, were discontinued from sale, and FDA moved the drug products to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Later, Corden Pharma Latina S.p.A. notified the Agency in writing that these drug products were no longer marketed and requested that the approval of the applications be withdrawn. In the Federal Register of June 21, 2017 (82 FR 28322 at 28326), the Agency issued a notice withdrawing approval of the applications, effective July 21, 2017. After reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CEFZIL (cefprozil) tablets, 250 mg and 500 mg, and CEFZIL (cefprozil) for oral suspension, 125 mg/ 5 mL and 250 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. We note that CEFZIL (cefprozil) tablets, 250 mg and 500 mg, and CEFZIL (cefprozil) for oral suspension, 125 mg/ 5 mL and 250 mg/5 mL, previously were approved with an indication for secondary bacterial infection of acute bronchitis (SBIAB). On October 3, 2016, FDA sent Corden Pharma Latina S.p.A. a Prior Approval Supplement Request letter seeking removal of the SBIAB indication from the labeling of these drug products. In response, on October 28, 2016, Corden Pharma Latina S.p.A. submitted supplements proposing to remove the indication. On November 22, 2016, FDA approved these supplements and the indication was 1 On May 26, 2011, Bristol-Myers Squibb transferred ownership of NDA 050664 and NDA 050665 to Corden Pharma Latina S.p.A. E:\FR\FM\11SEN1.SGM 11SEN1

Agencies

[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45937-45940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19664]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3031]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Tobacco Products, User Fees, Requirements for the 
Submission of Data Needed To Calculate User Fees for Domestic 
Manufacturers and Importers of Tobacco Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection for tobacco 
product user fees.

[[Page 45938]]


DATES: Submit either electronic or written comments on the collection 
of information by November 13, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3031 for ``Tobacco Products, User Fees, Requirements for the 
Submission of Data Needed to Calculate User Fees for Domestic 
Manufacturers and Importers of Tobacco Products.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Tobacco Products, User Fees, Requirements for the Submission of Data 
Needed To Calculate User Fees for Domestic Manufacturers and Importers 
of Tobacco Products

OMB Control Number 0910-0749--Extension

    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 (FD&C Act) and granted FDA authority to regulate 
the manufacture, marketing, and distribution of tobacco products to 
protect public health generally and to reduce tobacco use by minors.
    FDA issued a final rule that requires domestic manufacturers and 
importers of cigars and pipe tobacco to submit information needed to 
calculate the amount of user fees assessed under the

[[Page 45939]]

FD&C Act. FDA expanded its authority over tobacco products by issuing 
another final rule, ``Deeming Tobacco Products To Be Subject to the 
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking 
Prevention and Tobacco Control Act; Restrictions on the Sale and 
Distribution of Tobacco Products and Required Warning Statements for 
Tobacco Products'' (Deeming rule), deeming all products that meet the 
statutory definition of ``tobacco product,'' except accessories of the 
newly deemed tobacco products, to be subject to the FD&C Act. The 
Deeming rule, among other things, subjected domestic manufacturers and 
importers of cigars and pipe tobacco to the FD&C Act's user fee 
requirements. Consistent with the Deeming rule and the requirements of 
the FD&C Act, the user fee final rule requires the submission of the 
information needed to calculate user fee assessments for each 
manufacturer and importer of cigars and pipe tobacco to FDA.
    As noted, FDA issued a final rule that requires domestic tobacco 
product manufacturers and importers to submit information needed to 
calculate the amount of user fees assessed under the FD&C Act. The U. 
S. Department of Agriculture (USDA) had been collecting this 
information and provided FDA with the data the Agency needed to 
calculate the amount of user fees assessed to tobacco product 
manufacturers and importers. USDA ceased collecting this information in 
fiscal year 2015 (October 2014). USDA's information collection did not 
require OMB approval, per an exemption by Public Law 108-357, section 
642(b)(3). Consistent with the requirements of the FD&C Act, FDA 
requires the submission of this information to FDA now instead of USDA. 
FDA took this action to ensure that the Agency continues to have the 
information needed to calculate, assess, and collect user fees from 
domestic manufacturers and importers of tobacco products.
    Section 919(a) of the FD&C Act (21 U.S.C. 387s(a)) requires FDA to 
``assess user fees on, and collect such fees from, each manufacturer 
and importer of tobacco products'' subject to the tobacco product 
provisions of the FD&C Act (chapter IX of the FD&C Act). The total 
amount of user fees to be collected for each fiscal year is specified 
in section 919(b)(1) of the FD&C Act, and under section 919(a) FDA is 
to assess and collect a proportionate amount each quarter of the fiscal 
year. The FD&C Act provides for the total assessment to be allocated 
among the classes of tobacco products. The class allocation is based on 
each tobacco product class' volume of tobacco product removed into 
commerce. Within each class of tobacco products, an individual domestic 
manufacturer or importer is assessed a user fee based on its share of 
the market for that tobacco product class.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual      Hours per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
1150.5(a), (b)(1) and (2), and               658              12           7,896               3          23,688
 Form FDA 3852; General
 identifying information
 provided by manufacturers and
 importers of FDA regulated
 tobacco products and
 identification and removal
 information (monthly)..........
1150.5(b)(3); Certified copies               658              12           7,896               1           7,896
 (monthly)......................
1150.13; Submission of user fee              329               4           1,316               1           1,316
 information (Identifying
 information, fee amount, etc.
 (quarterly)....................
1150.15(a); Submission of user                 5               1               5              10              50
 fee dispute (annually).........
1150.15(d); Submission of                      3               1               3              10              30
 request for further review of
 dispute of user fee (annually).
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          32,980
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA estimates that 658 entities will submit tobacco product user 
fees. The entity count was derived from aggregate data provided by the 
Alcohol and Tobacco Tax and Trade Bureau (TTB), and reflects that in 
2017 there were 192 total permitted manufacturers and 466 permitted 
importers over all tobacco product types for which TTB collects excise 
taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe 
tobacco, and roll-your-own tobacco, excluding electronic nicotine 
delivery systems).
    The estimate of 658 respondents to provide the information 
requested from Sec.  1150.5(a), (b)(1) and (2) (21 CFR 1150.5(a), 
(b)(1) and (2)), and Form FDA 3852 reflects both reports of no removal 
of tobacco products into domestic commerce and reports of removal of 
tobacco product into domestic commerce. FDA estimates it will take 3 
hours for each of these submission types for a total of 23,688 hours. 
Under Sec.  1150.5(b)(3), these respondents are also expected to 
provide monthly certified copies of the returns and forms that relate 
to the removal of tobacco products into domestic commerce and the 
payment of Federal excise taxes imposed under chapter 52 of the 
Internal Revenue Code of 1986 to FDA. We estimate that each monthly 
report will take 1 hour for a total of 7,896 hours. The estimate of 329 
respondents to submit payment of user fee information under Sec.  
1150.13 reflects an average of half the number of domestic 
manufacturers and importers who may be subject to fees each fiscal 
quarter. FDA estimates the quarterly submission will take approximately 
1 hour for a total of 1,316 hours.
    FDA estimates that five of those respondents assessed user fees 
will dispute the amounts under Sec.  1150.15(a), for a total amount of 
50 hours. FDA also estimates that three respondents who dispute their 
user fees will ask for further review by FDA under Sec.  1150.15(d), 
for a total amount of 30 hours. FDA has only received one dispute 
submission since fiscal year 2015. Based on this data, the Agency does 
not believe we will receive more than five disputes and three requests 
for further reviews in the next 3 years.
    FDA estimates the total annual burden for this collection of 
information is 32,980 hours. The estimated burden for the information 
collection reflects an overall increase of 16,058 hours. We

[[Page 45940]]

attribute this adjustment to an increase in the number of entities 
submitting tobacco user fee information to FDA.

    Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19664 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.