81 FR 12501 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12501-12503 | |
| FR Document | 2016-05213 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12501-12503] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05213] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0049] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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) 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. DATES: Fax written comments on the collection of information by April 8, 2016. 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 emailed to [email protected]. All comments should be identified with the OMB control number 0910-0732. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. 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 On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) into law. This law amended the Food Drug and Cosmetic Act (the FD&C Act) and granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to [[Page 12502]] protect public health generally and to reduce tobacco use by minors. Section 904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) required each tobacco product manufacturer or importer, or an agent, to begin reporting to FDA no later than June 22, 2012, ``all constituents, including smoke constituents as applicable, identified by FDA as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product.'' Reports must be by the brand and by quantity in each brand and sub-brand. Section 904(c)(1) of the FD&C Act states that manufacturers of tobacco products not on the market as of June 22, 2009, must also provide information reportable under section 904(a)(3) at least 90 days prior to introducing the product into interstate commerce. FDA has taken several steps to identify harmful and potentially harmful constituents (HPHCs) to be reported under sections 904(a)(3) and (c)(1) 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). The guidance is available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, in the Federal Register of April 3, 2012 (77 FR 20034), FDA published a notice (the HPHC list notice) announcing the established list of HPHCs as required by section 904(e) of the FD&C Act and describing the criteria we used in identifying the HPHCs for the established list. Previously, FDA sought comment on both the criteria that would be used to identify HPHCs for the established list and a list of chemicals and chemical compounds that met the proposed criteria. The purpose of the information collection is to collect statutorily mandated information regarding HPHCs in tobacco products and tobacco smoke, by quantity in each brand and sub-brand. To facilitate the submission of HPHC information, FDA has developed Forms 3787a, 3787b, and 3787c in both paper and electronic formats. Manufacturers or importers, or their agents, may submit information either electronically or in paper format. The FDA eSubmitter tool provides electronic forms to streamline the data entry and submission process for reporting HPHCs. Users of eSubmitter may 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. Respondents finished reporting initial HPHC information under section 904(a)(3) in 2012, and this collection of information is in connection with the reporting requirements under section 904(c)(1) of the FD&C Act for tobacco products introduced into interstate commerce after June 22, 2009. In the Federal Register of November 13, 2015 (80 FR 70232), FDA published a 60-day notice requesting public comment on the proposed collection of information. Four comments were received; however, only one was PRA related. A comment stated that FDA has dramatically underestimated the annual number of responses that will be submitted from tobacco product manufacturers and importers. The comment contended that our estimate does not appear to be based on the Agency's experience with respect to ``new'' tobacco product submissions under section 910 of the FD&C Act. We have reconsidered our estimates, and agree with what we understand the comment to be saying, that we have not accounted for the submission of the two streamlined alternative substantial equivalent (SE) reports, one for label changes and one for product quantity changes, referred to as the ``Same Characteristics SE Report'' and the ``Product Quantity Change SE Report,'' respectively, and subsequent premarket authorization for a ``new tobacco product'' as defined under section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)). Based on FDA data, we estimate between 500 and700 (i.e., approximately 600) new tobacco products annually, as a result of manufacturers and importers submitting these streamlined submissions. We also estimate that the report of HPHC data in connection with these new tobacco products will take approximately 1 hour to prepare and submit. FDA has added a new line in the table for this category of new tobacco products. A comment also stated that the burden estimated for testing the quantities of HPHCs in cigarette filler and roll-your-own, smokeless, and smoke as 9.42 hours, 12.06 hours and 23.64 hours respectively, per product, has been dramatically underestimated. The comment contends that HPHC testing may more realistically be expected to take 7 to 12 weeks per product. FDA does not agree with this comment. The Agency based its estimates on its understanding as to how long the tests themselves take, as opposed to the length of time between when a manufacturer or importer may first request that a test be done and then receives the test results from an internal or independent laboratory. Furthermore, a comment stated that the burden estimated for the time required to report HPHC information to the Agency has been underestimated. The comment contends that in one entity's experience, the time required to report on the testing of a cigarette may be expected to take around 200 hours, taking into account the time required to compile the requisite information and to complete, review and edit the associated form. FDA disagrees with this comment as we believe the estimates for testing the quantities of HPHCs are accurate. Additionally, we note that the comment did not contain any data to support its contention. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Information collected 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................. 78 0.79 62 1.82............ 113 Roll-Your-Own............. 39 0.21 8 0.43 (26 3 minutes). Smokeless................. 52 0.21 11 0.63 (38 7 minutes). --------------------------------------------------------------------------------- [[Page 12503]] Total................. .............. .............. .............. ................ 123 2. Testing of HPHC Quantities in Products: Cigarette Filler.......... 78 0.79 62 9.42............ 584 Roll-Your-Own............. 39 0.21 8 9.42............ 75 Smokeless................. 52 0.21 11 12.06........... 133 --------------------------------------------------------------------------------- Total................. .............. .............. .............. ................ 792 3. Testing of HPHC Quantities in Mainstream Smoke: Cigarette: International 78 0.79 62 23.64........... 1,466 Oraganization for Standardization (ISO) Regimen. Cigarette: Health Canada 78 0.79 62 23.64........... 1,466 Regimen. --------------------------------------------------------------------------------- Total................. .............. .............. .............. ................ 2,932 4. Additional HPHC reports: \2\ Cigarette Filler.......... 78 2.56 200 1............... 200 Roll-Your-Own............. 39 5.12 200 1............... 200 Smokeless................. 52 3.84 200 1............... 200 --------------------------------------------------------------------------------- Total................. .............. .............. .............. ................ 600 --------------------------------------------------------------------------------- Total Section .............. .............. .............. ................ 4,447 904(c)(1) Reporting Burden Hours. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ HPHC reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC measures will be the same as the original report. Table 1 contains estimates for new product information received annually under section 904(c)(1) of the FD&C Act. Manufacturers must report HPHC information under section 904(c)(1) of the FD&C Act at least 90 days prior to delivery for introduction into interstate commerce. The total annual burden for this collection of information is estimated to be 4,447 hours. The burden estimate for this collection of information includes the time it will take to test the products and prepare the HPHC report. Table 1 indicates that 169 respondents will submit HPHC reports when new products enter the market. Section 1 of the table addresses the time required for manufacturers to report their company information. We estimate that the time to report HPHC information is no more than 1.82 hours for cigarettes, 0.42 hours for roll-your-own, and 0.63 hours for smokeless tobacco products for each response regardless of whether the paper or electronic form (Form FDA 3787) is used. (The estimated times to report smokeless tobacco products (0.63 hour) and roll-your-own tobacco products (0.43 hour) are lower than the estimated reporting time for cigarette products because fewer HPHCs are normally reported for these two types of products. The total annual burden for reporting company and product information is 123 hours. Section 2 of the table addresses the time required for manufacturers to test quantities of HPHCs in their products. The burden hour estimates include the time needed to test the tobacco products, draft testing reports, and draft the report for FDA. For cigarette filler, smokeless, and roll-your-own products, we estimate the burden to be 792 annual burden hours. The burden for each product type reflects our estimate of the time to test the tobacco products (i.e., carry out laboratory work). In addition to addressing the time required to report information and test quantities of HPHCs in tobacco products, section 3 of table 1 addresses the time required for manufacturers to test quantities of HPHCs in cigarette smoke. The burden estimates include testing the tobacco products, drafting testing reports, and drafting the report for FDA. We estimate the annualized burden for this section to be 2,932 hours. The annual burden reflects our estimate to test the tobacco products (i.e., carry out laboratory work). The burden estimate assumes that manufacturers report HPHC quantities in cigarette mainstream smoke according to the two smoking regimens described in the table. As stated previously, FDA expects to receive 600 additional HPHC reports at 1 hour per response for a total of 600 hours. The estimated total annual burden for the reporting of HPHC under section 904(c)(1) of the FD&C Act is 4,447 hours. Dated: March 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05213 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12501
Silver Spring, MD 20993–0002. Send adverse reactions related to HCT/Ps to DEPARTMENT OF HEALTH AND
one self-addressed adhesive label to supplement the general instructions HUMAN SERVICES
assist the office in processing your accompanying the MedWatch
requests. The guidance may also be mandatory reporting form, Form FDA Food and Drug Administration
obtained by mail by calling CBER at 1– 3500A. The guidance announced in this [Docket No. FDA–2012–D–0049]
800–835–4709 or 240–402–8010. See notice finalizes the draft guidance of the
the SUPPLEMENTARY INFORMATION section same title dated February 2015. Agency Information Collection
for electronic access to the guidance Activities; Submission for Office of
document. The guidance is being issued
Management and Budget Review;
consistent with FDA’s good guidance
FOR FURTHER INFORMATION CONTACT: Lori Comment Request; Reporting Harmful
practices regulation (21 CFR 10.115). and Potentially Harmful Constituents
J. Churchyard, Center for Biologics The guidance represents the current
Evaluation and Research, Food and in Tobacco Products and Tobacco
thinking of FDA on Investigating and Smoke Under the Federal Food, Drug,
Drug Administration, 10903 New Reporting Adverse Reactions Related to
Hampshire Ave., Bldg. 71, Rm. 7301, and Cosmetic Act
Human Cells, Tissues, and Cellular and
Silver Spring, MD 20993–0002, 240– AGENCY: Food and Drug Administration,
Tissue-Based Products Regulated Solely
402–7911. HHS.
under Section 361 of the Public Health
SUPPLEMENTARY INFORMATION: ACTION: Notice.
Service Act and 21 CFR part 1271;
I. Background Guidance for Industry. It does not SUMMARY: The Food and Drug
FDA is announcing the availability of establish any rights for any person and Administration (FDA) is announcing
a document entitled ‘‘Investigating and is not binding on FDA or the public. that a proposed collection of
Reporting Adverse Reactions Related to You can use an alternative approach if information has been submitted to the
Human Cells, Tissues, and Cellular and it satisfies the requirements of the Office of Management and Budget
Tissue-Based Products (HCT/Ps) applicable statutes and regulations. (OMB) for review and clearance under
Regulated Solely under Section 361 of II. Paperwork Reduction Act of 1995 the Paperwork Reduction Act of 1995.
the Public Health Service Act and 21 DATES: Fax written comments on the
CFR part 1271; Guidance for Industry.’’ The guidance refers to previously collection of information by April 8,
The guidance provides establishments approved collections of information 2016.
that manufacture HCT/Ps, with found in FDA regulations. These ADDRESSES: To ensure that comments on
recommendations for complying with collections of information are subject to the information collection are received,
the requirements for investigating and review by the Office of Management and OMB recommends that written
reporting adverse reactions involving Budget (OMB) under the Paperwork comments be faxed to the Office of
communicable disease in recipients of Reduction Act of 1995 (44 U.S.C. 3501– Information and Regulatory Affairs,
HCT/Ps that are regulated solely under 3520). The collections of information in OMB, Attn: FDA Desk Officer, FAX:
section 361 of the Public Health Service 202–395–7285, or emailed to oira_
21 CFR part 1271 have been approved
Act (PHS Act) and 21 CFR part 1271 submission@omb.eop.gov. All
under OMB control number 0910–0543;
(361 HCT/Ps). comments should be identified with the
In the Federal Register of February and the collections of information in
MedWatch Form FDA 3500A has been OMB control number 0910–0732. Also
20, 2015 (80 FR 9267), FDA announced
approved under OMB control number include the FDA docket number found
the availability of the draft guidance of
0910–0291. in brackets in the heading of this
the same title dated February 2015. FDA
document.
received several comments on the draft III. Electronic Access
guidance and those comments were FOR FURTHER INFORMATION CONTACT: FDA
considered as the guidance was Persons with access to the Internet PRA Staff, Office of Operations, Food
finalized. In addition, editorial changes may obtain the guidance at either and Drug Administration, 8455
were made to improve clarity. http://www.fda.gov/ Colesville Rd., COLE–14526, Silver
The guidance supplements section BiologicsBloodVaccines/ Spring, MD 20993–0002, PRAStaff@
XXII of FDA’s guidance entitled GuidanceCompliance fda.hhs.gov.
‘‘Guidance for Industry: Current Good RegulatoryInformation/Guidances/ SUPPLEMENTARY INFORMATION: In
Tissue Practice (CGTP) and Additional default.htm or http:// compliance with 44 U.S.C. 3507, FDA
Requirements for Manufacturers of www.regulations.gov. has submitted the following proposed
Human Cells, Tissues, and Cellular and collection of information to OMB for
Tissue-Based Products (HCT/Ps)’’ dated Dated: March 2, 2016.
review and clearance.
December 2011 by providing additional Leslie Kux,
recommendations specific to the Associate Commissioner for Policy.
Reporting Harmful and Potentially
responsibilities to investigate Harmful Constituents in Tobacco
[FR Doc. 2016–05215 Filed 3–8–16; 8:45 am]
complaints of adverse reactions Products and Tobacco Smoke Under
BILLING CODE 4164–01–P the Federal Food, Drug, and Cosmetic
concerning 361 HCT/Ps under 21 CFR
1271.160(b)(2), 21 CFR 1271.320 and 21 Act OMB Control Number 0910–0732—
CFR 1271.350(a)(1) and, supersedes the Extension
guidance entitled ‘‘Guidance for On June 22, 2009, the President
Lhorne on DSK5TPTVN1PROD with NOTICES
Industry: MedWatch Form FDA 3500A: signed the Family Smoking Prevention
Mandatory Reporting of Adverse and Tobacco Control Act (Pub. L. 111–
Reactions Related to Human Cells, 31) into law. This law amended the
Tissues, and Cellular and Tissue-Based Food Drug and Cosmetic Act (the FD&C
Products (HCT/Ps)’’ dated November Act) and granted FDA authority to
2005. The guidance provides updated regulate the manufacture, marketing,
information specific to reporting and distribution of tobacco products to
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![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12503
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Information collected responses per Total hours
respondents responses per response
respondent
Total .................................................................................................. ........................ ........................ ........................ .............................. 123
2. Testing of HPHC Quantities in Products:
Cigarette Filler ......................................................................................... 78 0.79 62 9.42 ...................... 584
Roll-Your-Own ......................................................................................... 39 0.21 8 9.42 ...................... 75
Smokeless ............................................................................................... 52 0.21 11 12.06 .................... 133
Total .................................................................................................. ........................ ........................ ........................ .............................. 792
3. Testing of HPHC Quantities in Mainstream Smoke:
Cigarette: International Oraganization for Standardization (ISO) Regi- 78 0.79 62 23.64 .................... 1,466
men.
Cigarette: Health Canada Regimen ........................................................ 78 0.79 62 23.64 .................... 1,466
Total .................................................................................................. ........................ ........................ ........................ .............................. 2,932
4. Additional HPHC reports: 2
Cigarette Filler ......................................................................................... 78 2.56 200 1 ........................... 200
Roll-Your-Own ......................................................................................... 39 5.12 200 1 ........................... 200
Smokeless ............................................................................................... 52 3.84 200 1 ........................... 200
Total .................................................................................................. ........................ ........................ ........................ .............................. 600
Total Section 904(c)(1) Reporting Burden Hours ..................... ........................ ........................ ........................ .............................. 4,447
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 HPHC reports for identical products (e.g., under different brand or sub-brand names) in which the HPHC measures will be the same as the original report.
Table 1 contains estimates for new smokeless, and roll-your-own products, DEPARTMENT OF HEALTH AND
product information received annually we estimate the burden to be 792 annual HUMAN SERVICES
under section 904(c)(1) of the FD&C Act. burden hours. The burden for each
Manufacturers must report HPHC product type reflects our estimate of the Food and Drug Administration
information under section 904(c)(1) of time to test the tobacco products (i.e.,
the FD&C Act at least 90 days prior to carry out laboratory work). [Docket No. FDA–2016–N–0735]
delivery for introduction into interstate
In addition to addressing the time Agency Information Collection
commerce. The total annual burden for
this collection of information is required to report information and test Activities; Proposed Collection;
estimated to be 4,447 hours. The burden quantities of HPHCs in tobacco Comment Request; Superimposed
estimate for this collection of products, section 3 of table 1 addresses Text in Direct-to-Consumer Promotion
information includes the time it will the time required for manufacturers to of Prescription Drugs
take to test the products and prepare the test quantities of HPHCs in cigarette
HPHC report. Table 1 indicates that 169 smoke. The burden estimates include AGENCY: Food and Drug Administration,
respondents will submit HPHC reports testing the tobacco products, drafting HHS.
when new products enter the market. testing reports, and drafting the report ACTION: Notice.
Section 1 of the table addresses the for FDA. We estimate the annualized
time required for manufacturers to burden for this section to be 2,932 SUMMARY: The Food and Drug
report their company information. We hours. The annual burden reflects our Administration (FDA) is announcing an
estimate that the time to report HPHC estimate to test the tobacco products opportunity for public comment on the
information is no more than 1.82 hours (i.e., carry out laboratory work). The proposed collection of certain
for cigarettes, 0.42 hours for roll-your- burden estimate assumes that information by the Agency. Under the
own, and 0.63 hours for smokeless manufacturers report HPHC quantities Paperwork Reduction Act of 1995 (the
tobacco products for each response in cigarette mainstream smoke PRA), Federal Agencies are required to
regardless of whether the paper or according to the two smoking regimens publish notice in the Federal Register
electronic form (Form FDA 3787) is described in the table. concerning each proposed collection of
used. (The estimated times to report information and to allow 60 days for
smokeless tobacco products (0.63 hour) As stated previously, FDA expects to
public comment in response to the
and roll-your-own tobacco products receive 600 additional HPHC reports at
notice. This notice solicits comments on
(0.43 hour) are lower than the estimated 1 hour per response for a total of 600
research entitled ‘‘Superimposed Text
reporting time for cigarette products hours. The estimated total annual in Direct-to-Consumer Promotion of
because fewer HPHCs are normally burden for the reporting of HPHC under Prescription Drugs.’’ This study will
reported for these two types of products. section 904(c)(1) of the FD&C Act is examine how the size and presentation
The total annual burden for reporting 4,447 hours. of superimposed text (supers) influences
company and product information is Dated: March 2, 2016. the comprehension of direct-to-
123 hours. Leslie Kux, consumer (DTC) television
Lhorne on DSK5TPTVN1PROD with NOTICES
Section 2 of the table addresses the advertisements for prescription drugs.
time required for manufacturers to test Associate Commissioner for Policy.
quantities of HPHCs in their products. [FR Doc. 2016–05213 Filed 3–8–16; 8:45 am] DATES: Submit either electronic or
The burden hour estimates include the BILLING CODE 4164–01–P written comments on the collection of
time needed to test the tobacco information by May 9, 2016.
products, draft testing reports, and draft ADDRESSES: You may submit comments
the report for FDA. For cigarette filler, as follows:
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Document Created: 2016-03-09 00:13:35
Document Modified: 2016-03-09 00:13:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by April 8, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 12501 |
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