Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act, 744-747 [2019-00448]

Download as PDF 744 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No. 0970–0198] Proposed Information Collection Activity; Comment Request Proposed Projects: Title: FY 2020–2022 Child Care and Development Fund Plan for Tribes (ACF–118A) Description: The Child Care and Development Fund (CCDF) Plan (the Plan) for Tribes is required from each CCDF Lead agency in accordance with Section 658E of the Child Care and Development Block Grant Act of 1990 (CCDBG Act), as amended, CCDBG Act of 2014 (Pub. L. 113–186), and 42 U.S.C 9858. The Plan, submitted on the ACF– 118A, is required triennially, and remains in effect for three years. The Plan provides ACF and the public with a description of, and assurance about the States’ and Territories’ child care programs. These Plans are the applications for CCDF funds. This Notice is required by the Paperwork Reduction Act (PRA). The PRA requires Federal agencies to request approval from the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) for any information collection that will ask the same question of ten or more persons. The process includes publication of an initial Federal Register Notice (FRN) allowing 60 days for public comments on the initial plan for information collection, the publication of a second FRN allowing 30 days for public comment on the final proposed information collection, and review and approval by the OMB Office of Information and Regulatory Affairs. The Office of Child Care (OCC) has revised the FY 2020–2022 CCDF Plan Preprint for Tribes to align with the CCDF Final Rule published on September 30, 2016. In making the revisions, consideration was given to minimize the burden of the collection of information on respondents. The revised document contains revisions to improve the accuracy and clarity of policy questions, definitions, and guidance in order to improve the quality of information that is collected. Consistent with the statute and regulations, ACF requests revisions of the ACF–118A to align with the requirements of the CCDF Final Rule. Respondents: Tribal CCDF Lead Agencies (260). ANNUAL BURDEN ESTIMATES Number of respondents Instrument amozie on DSK3GDR082PROD with NOTICES1 ACF—118A Part I (for all tribes) ..................................................................... ACF—118A Part II (for medium and large allocation tribes only) ................... Estimated Total Annual Burden Hours: 20,457. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 260 106 other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–00386 Filed 1–30–19; 8:45 am] BILLING CODE 4184–81–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0049] Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act 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 SUMMARY: PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 Number of responses per respondent 0.33 0.33 Average burden hours per response 120 144 Total burden hours 15,420 5,037 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 reporting harmful and potentially harmful constituents (HPHCs). Submit either electronic or written comments on the collection of information by April 1, 2019. 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 April 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 1, 2019. 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: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the E:\FR\FM\31JAN1.SGM 31JAN1 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices amozie on DSK3GDR082PROD with NOTICES1 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– 2012–D–0049 for ‘‘Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act.’’ 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 VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 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. 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 PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 745 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. Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910–0732— Extension The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act), enacted on June 22, 2009, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))). In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA’s tobacco product authority (final deeming rule) (81 FR 28974). Chapter IX of the FD&C Act now applies to newly regulated products, including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and (c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of an initial report from each tobacco product manufacturer or importer, or agents thereof, listing all constituents, including smoke constituents as applicable, identified as HPHC to health by FDA. Reports must be by brand and by quantity in each brand and subbrand. We note that for cigarettes, smokeless tobacco, cigarette E:\FR\FM\31JAN1.SGM 31JAN1 746 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices filler, and RYO tobacco products, this initial reporting was completed in 2012. Section 904(c)(1) of the FD&C Act provides that manufacturers of tobacco products not on the market as of June 22, 2009, must also provide the information reportable under section 904(a)(3) at least 90 days prior to introducing the product into interstate commerce.1 FDA has taken several steps to identify HPHCs to be reported under section 904 of the FD&C Act, including issuing a guidance discussing FDA’s current thinking on the meaning of the term ‘‘harmful and potentially harmful constituent’’ in the context of implementing the HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387, January 31, 2011, revised guidance issued August 2016). The guidance is available on the internet at https://www.fda.gov/ TobaccoProducts/GuidanceCompliance RegulatoryInformation/ucm241339.htm. The current established list of HPHCs also is available on the internet at https://www.fda.gov/downloads/ TobaccoProducts/Labeling/ RulesRegulationsGuidance/ UCM297828.pdf (77 FR 20034, April 3, 2012). The purpose of the information collection is to collect statutorily mandated information regarding HPHCs in tobacco products and tobacco smoke, by brand and by quantity in each brand and subbrand. To facilitate the submission of HPHC information, Forms FDA 3787a, 3787b, and 3787c for cigarettes, smokeless tobacco products, and RYO tobacco products, respectively, in both paper and electronic formats, are available. Additionally, FDA is developing forms to facilitate the submission of HPHC information for the newly deemed tobacco products. We intend to model these forms on the current HPHC reporting forms (i.e., Forms FDA 3787a, 3787b, and 3787c). A proposed information collection for newly deemed products will be published in a separate Federal Register notice, and we will solicit comments on that collection at that time. Manufacturers or importers, or their agents, may submit HPHC information either electronically or in paper format. The FDA eSubmitter tool provides electronic forms to streamline the data entry and submission process for reporting HPHCs for cigarettes, smokeless tobacco products, and RYO tobacco products. Users of eSubmitter may populate an FDA-created Excel file and import data into eSubmitter. Whether respondents decide to submit reports electronically or on paper, each form provides instructions for completing and submitting HPHC information to FDA. The forms contain fields for company information, product information, and HPHC information. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Reporting for Section 904(c)(1) Products 1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms Cigarette ............................................................................... RYO ..................................................................................... Smokeless ............................................................................ 67 46 42 0.67 0.033 0.54 45 1.5 23 1.82 0.43 0.63 82 1 14 Total .............................................................................. ........................ ........................ ........................ ........................ 97 2. Testing of HPHC Quantities in Products Cigarette Filler and RYO ..................................................... Smokeless ............................................................................ 46 42 0.033 0.54 1.5 23 9.42 12.06 14 277 Total .............................................................................. ........................ ........................ ........................ ........................ 291 3. Testing of HPHC Quantities in Mainstream Smoke Cigarette: ISO Regimen ....................................................... Cigarette: Health Canada Regimen ..................................... 67 67 0.67 0.67 45 45 23.64 23.64 1,064 1,064 Total .............................................................................. ........................ ........................ ........................ ........................ 2,128 ........................ ........................ ........................ ........................ 2,516 Total Section 904(c)(1) Reporting Burden Hours amozie on DSK3GDR082PROD with NOTICES1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden for this collection of information is estimated to be 2,516 hours. The burden estimate for this collection of information includes the time it will take to read the instructions, test the products, and prepare the HPHC report. In arriving at this burden estimate, FDA estimated the number of tobacco products to be reported under the requirements of section 904(c)(1) of the FD&C Act annually to FDA. Section 1 of table 1 estimates that 155 respondents (67 cigarette manufacturers or importers, 46 RYO tobacco manufacturers, 42 smokeless manufacturers) will submit 97 HPHC reports annually. This section addresses the time required for manufacturers and importers (or their agents), who must report their product information to FDA 1 Note that section 904(c)(1) testing and reporting requirements are separate from the requirements that must be satisfied before a new tobacco product (sections 905 and 910 of the FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be marketed. VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\31JAN1.SGM 31JAN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices under section 904(c)(1) of the FD&C Act at least 90 days prior to delivery for introduction into interstate commerce for all new products, to report their company information to FDA through the use of the electronic portal or paper forms. The company information reported includes: Company name; mailing address; telephone and Fax numbers; FDA Establishment Identifier number; Data Universal Numbering System number; and point of contact name, mailing address, and telephone and Fax numbers, as applicable. It also addresses the time required for manufacturers and importers to report their product information by entering certain testing information into the electronic or paper forms. The product information includes: Brand and subbrand name; unique product identification number; type of product identification number; product category and subcategory; and mean weight and standard deviation of tobacco in product. We estimate that the burden to enter both the company and product information is no more than 1.82 hours for cigarettes, 0.43 hours for RYO, and 0.63 hours for smokeless tobacco products regardless of whether the paper or electronic Form FDA series 3787 is used. The time to report per tobacco product types varies because the number of HPHCs varies by tobacco product category. The estimated number of responses under section 904(c)(1) is based on FDA’s experience and the past 3 years’ actual responses to FDA under this provision of the FD&C Act for statutorily regulated products. Section 2 of table 1 estimates that 88 respondents (46 cigarette filler and RYO tobacco manufacturers and importers and 42 smokeless manufacturers) will test quantities of HPHCs in an average of 24.5 products annually. This section addresses the time required for manufacturers and importers (or their agents) who must test HPHC quantities in products. The burden estimates include the burden to test the tobacco products, draft testing reports, and submit the report to FDA. The total expected burden for this section is 291 hours. Section 3 of table 1 addresses the time required for manufacturers and importers to test quantities for HPHCs in cigarette smoke. The burden estimates include: The burden to test the number of replicate measurements; test date range; manufacture date range; extraction method; separation method; detection method; and mean quantity and standard deviation of HPHCs and VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 includes the burden to test the tobacco products, draft testing reports, and submit the report to FDA. The annual burden reflects our estimate of the time it takes to test the tobacco products (i.e., carry out laboratory work). The burden estimate assumes that manufacturers and importers report HPHC quantities in cigarette mainstream smoke according to the two smoking regimens. The total expected burden is 2,128 hours for this section. The total estimated burden for this information collection is 2,516 hours and 139 responses. Our estimated burden for the information collection reflects an overall decrease of 2,125 hours and a corresponding decrease of 142 responses. We attribute this decrease to updated information on the number of submissions we received over the last few years. Dated: January 11, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–00448 Filed 1–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0070] Microbiology Devices Panel Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Microbiology Devices Panel. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on March 8, 2019, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s phone number is 301–977–8900; additional information available online at: https:// www3.hilton.com/en/hotels/maryland/ hilton-washington-dc-northgaithersburg-GAIGHHF/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ SUMMARY: PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 747 AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–0002, Aden.Asefa@ fda.hhs.gov, 301–796–0400, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the 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 Agency’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: On March 8, 2019, the committee will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV) nucleic acid. These approaches will take into consideration scientific data generated since the approval of the first High Risk (HR) HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection. Topics to be addressed at the meeting include clinical study design and comparator methods. Additionally, the committee will discuss potential changes to the HR HPV device indications for use considering continually evolving cervical cancer screening guidelines. The committee will provide expert feedback regarding the benefits and risks from the adoption of changes in each of the above topics and make recommendations for future HR HPV device evaluation strategies that are both scientifically rigorous and least burdensome. 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/ E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 744-747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00448]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reporting Harmful and Potentially Harmful Constituents 
in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and 
Cosmetic Act

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 reporting harmful and potentially harmful 
constituents (HPHCs).

DATES: Submit either electronic or written comments on the collection 
of information by April 1, 2019.

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 April 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 1, 2019. 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

[[Page 745]]

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-2012-D-0049 for ``Reporting Harmful and Potentially Harmful 
Constituents in Tobacco Products and Tobacco Smoke Under the Federal 
Food, Drug, and Cosmetic Act.'' 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, 
PRAStaff@fda.hhs.gov.

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.

Reporting Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic 
Act

OMB Control Number 0910-0732--Extension

    The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-
31) (Tobacco Control Act), enacted on June 22, 2009, amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with 
the authority to regulate the manufacture, marketing, and distribution 
of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and 
smokeless tobacco products to protect the public health and to reduce 
tobacco use by minors. The Tobacco Control Act also gave FDA the 
authority to issue regulations deeming other products that meet the 
statutory definition of a tobacco product to be subject to chapter IX 
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
    In accordance with that authority, on May 10, 2016, FDA issued a 
final rule deeming all products that meet the statutory definition of 
tobacco product, except accessories of newly deemed tobacco products, 
to be subject to FDA's tobacco product authority (final deeming rule) 
(81 FR 28974).
    Chapter IX of the FD&C Act now applies to newly regulated products, 
including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and 
(c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of 
an initial report from each tobacco product manufacturer or importer, 
or agents thereof, listing all constituents, including smoke 
constituents as applicable, identified as HPHC to health by FDA. 
Reports must be by brand and by quantity in each brand and subbrand. We 
note that for cigarettes, smokeless tobacco, cigarette

[[Page 746]]

filler, and RYO tobacco products, this initial reporting was completed 
in 2012.
    Section 904(c)(1) of the FD&C Act provides that manufacturers of 
tobacco products not on the market as of June 22, 2009, must also 
provide the information reportable under section 904(a)(3) at least 90 
days prior to introducing the product into interstate commerce.\1\
---------------------------------------------------------------------------

    \1\ Note that section 904(c)(1) testing and reporting 
requirements are separate from the requirements that must be 
satisfied before a new tobacco product (sections 905 and 910 of the 
FD&C Act (21 U.S.C. 387e and 387j)), or modified risk tobacco 
product (section 911 of the FD&C Act (21 U.S.C. 387k)) may be 
marketed.
---------------------------------------------------------------------------

    FDA has taken several steps to identify HPHCs to be reported under 
section 904 of the FD&C Act, including issuing a guidance discussing 
FDA's current thinking on the meaning of the term ``harmful and 
potentially harmful constituent'' in the context of implementing the 
HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387, 
January 31, 2011, revised guidance issued August 2016). The guidance is 
available on the internet at https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. The current 
established list of HPHCs also is available on the internet at https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM297828.pdf (77 FR 20034, April 3, 2012).
    The purpose of the information collection is to collect statutorily 
mandated information regarding HPHCs in tobacco products and tobacco 
smoke, by brand and by quantity in each brand and subbrand.
    To facilitate the submission of HPHC information, Forms FDA 3787a, 
3787b, and 3787c for cigarettes, smokeless tobacco products, and RYO 
tobacco products, respectively, in both paper and electronic formats, 
are available. Additionally, FDA is developing forms to facilitate the 
submission of HPHC information for the newly deemed tobacco products. 
We intend to model these forms on the current HPHC reporting forms 
(i.e., Forms FDA 3787a, 3787b, and 3787c). A proposed information 
collection for newly deemed products will be published in a separate 
Federal Register notice, and we will solicit comments on that 
collection at that time.
    Manufacturers or importers, or their agents, may submit HPHC 
information either electronically or in paper format. The FDA 
eSubmitter tool provides electronic forms to streamline the data entry 
and submission process for reporting HPHCs for cigarettes, smokeless 
tobacco products, and RYO tobacco products. Users of eSubmitter may 
populate an FDA-created Excel file and import data into eSubmitter. 
Whether respondents decide to submit reports electronically or on 
paper, each form provides instructions for completing and submitting 
HPHC information to FDA. The forms contain fields for company 
information, product information, and HPHC information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
                                    Reporting for Section 904(c)(1) Products
----------------------------------------------------------------------------------------------------------------
      1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
Cigarette.......................              67            0.67              45            1.82              82
RYO.............................              46           0.033             1.5            0.43               1
Smokeless.......................              42            0.54              23            0.63              14
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............              97
----------------------------------------------------------------------------------------------------------------
                                    2. Testing of HPHC Quantities in Products
----------------------------------------------------------------------------------------------------------------
Cigarette Filler and RYO........              46           0.033             1.5            9.42              14
Smokeless.......................              42            0.54              23           12.06             277
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............             291
----------------------------------------------------------------------------------------------------------------
                                3. Testing of HPHC Quantities in Mainstream Smoke
----------------------------------------------------------------------------------------------------------------
Cigarette: ISO Regimen..........              67            0.67              45           23.64           1,064
Cigarette: Health Canada Regimen              67            0.67              45           23.64           1,064
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............           2,128
                                 -------------------------------------------------------------------------------
        Total Section 904(c)(1)   ..............  ..............  ..............  ..............           2,516
         Reporting Burden Hours.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden for this collection of information is estimated to be 
2,516 hours. The burden estimate for this collection of information 
includes the time it will take to read the instructions, test the 
products, and prepare the HPHC report.
    In arriving at this burden estimate, FDA estimated the number of 
tobacco products to be reported under the requirements of section 
904(c)(1) of the FD&C Act annually to FDA.
    Section 1 of table 1 estimates that 155 respondents (67 cigarette 
manufacturers or importers, 46 RYO tobacco manufacturers, 42 smokeless 
manufacturers) will submit 97 HPHC reports annually. This section 
addresses the time required for manufacturers and importers (or their 
agents), who must report their product information to FDA

[[Page 747]]

under section 904(c)(1) of the FD&C Act at least 90 days prior to 
delivery for introduction into interstate commerce for all new 
products, to report their company information to FDA through the use of 
the electronic portal or paper forms.
    The company information reported includes: Company name; mailing 
address; telephone and Fax numbers; FDA Establishment Identifier 
number; Data Universal Numbering System number; and point of contact 
name, mailing address, and telephone and Fax numbers, as applicable. It 
also addresses the time required for manufacturers and importers to 
report their product information by entering certain testing 
information into the electronic or paper forms.
    The product information includes: Brand and subbrand name; unique 
product identification number; type of product identification number; 
product category and subcategory; and mean weight and standard 
deviation of tobacco in product.
    We estimate that the burden to enter both the company and product 
information is no more than 1.82 hours for cigarettes, 0.43 hours for 
RYO, and 0.63 hours for smokeless tobacco products regardless of 
whether the paper or electronic Form FDA series 3787 is used. The time 
to report per tobacco product types varies because the number of HPHCs 
varies by tobacco product category.
    The estimated number of responses under section 904(c)(1) is based 
on FDA's experience and the past 3 years' actual responses to FDA under 
this provision of the FD&C Act for statutorily regulated products.
    Section 2 of table 1 estimates that 88 respondents (46 cigarette 
filler and RYO tobacco manufacturers and importers and 42 smokeless 
manufacturers) will test quantities of HPHCs in an average of 24.5 
products annually. This section addresses the time required for 
manufacturers and importers (or their agents) who must test HPHC 
quantities in products. The burden estimates include the burden to test 
the tobacco products, draft testing reports, and submit the report to 
FDA. The total expected burden for this section is 291 hours.
    Section 3 of table 1 addresses the time required for manufacturers 
and importers to test quantities for HPHCs in cigarette smoke. The 
burden estimates include: The burden to test the number of replicate 
measurements; test date range; manufacture date range; extraction 
method; separation method; detection method; and mean quantity and 
standard deviation of HPHCs and includes the burden to test the tobacco 
products, draft testing reports, and submit the report to FDA. The 
annual burden reflects our estimate of the time it takes to test the 
tobacco products (i.e., carry out laboratory work). The burden estimate 
assumes that manufacturers and importers report HPHC quantities in 
cigarette mainstream smoke according to the two smoking regimens. The 
total expected burden is 2,128 hours for this section.
    The total estimated burden for this information collection is 2,516 
hours and 139 responses.
    Our estimated burden for the information collection reflects an 
overall decrease of 2,125 hours and a corresponding decrease of 142 
responses. We attribute this decrease to updated information on the 
number of submissions we received over the last few years.

    Dated: January 11, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00448 Filed 1-30-19; 8:45 am]
 BILLING CODE 4164-01-P
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