80 FR 22202 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 76 (April 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 76 (April 21, 2015)
| Page Range | 22202-22204 | |
| FR Document | 2015-09092 |
[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)] [Notices] [Pages 22202-22204] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09092] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0386] Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 proposed extension of an existing collection of information pertaining to registration and product listing for owners and operators of domestic tobacco product establishments and listing of ingredients in tobacco products. DATES: Submit either electronic or written comments on the collection of information by June 22, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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, 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. Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products (OMB Control Number 0910-0650)--Extension) On June 22, 2009, the President signed the Tobacco Control Act (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301) by, among other things, adding a chapter granting FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905(b) of the FD&C Act (21 U.S.C. 387e(b)), as amended by the Tobacco Control Act, requires that every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products register with FDA the name, places of business, and all establishments owned or operated by that person. Every person must register by December 31 of each year. Section 905(c) of the FD&C Act requires that first-time persons engaging [[Page 22203]] in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person. Section 905(d) states that persons required to register under section 905(b) or 905(c) of the FD&C Act shall register any additional establishment that they own or operate in any state which begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 905(h) of the FD&C Act addresses foreign establishment registration requirements, which will go into effect when regulations are promulgated by the Secretary. Section 905(i)(1) of the FD&C Act, as amended by the Tobacco Control Act, requires that all registrants shall, at the time of registration under any such subsection, file with FDA a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution, along with certain accompanying consumer information, such as all labeling and a representative sampling of advertisements. Section 904(a)(1) of the FD&C Act (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, requires each tobacco product manufacturer or importer, or agent thereof, to submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand or by quantity in each brand and sub-brand. Since the Tobacco Control Act was enacted on June 22, 2009, the information required under section 904(a)(1) of the FD&C Act must be submitted to FDA by December 22, 2009, and include the ingredients added as of the date of submission. Section 904(c) of the FD&C Act also requires submission of information whenever additives, or the quantities of additives, are changed. FDA issued guidance documents on both: (1) ``Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments'' and (2) ``Listing of Ingredients in Tobacco Products'' to assist persons making such submissions to FDA under the Tobacco Control Act. While electronic submission of registration and product listing information and ingredient listing information are not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data management and collection. To that end, FDA designed electronic submission applications to streamline the data entry process for registration and product listing and for ingredient listing. These tools allow for importation of large quantities of structured data, attachment of files (e.g., in PDFs and certain media files), and automatic acknowledgement of FDA's receipt of submissions. FDA also developed paper forms (Form FDA 3741--Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments, and Form FDA 3742--Listing of Ingredients in Tobacco Products) as an alternative submission tool. Both the electronic submission application and the paper forms can be accessed at http://www.fda.gov/tobacco. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average operating and Activity respondents responses per responses burden per Total hours maintenance respondent response costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Form FDA 3741: Registration and Product Listing for 125 1.6 200 3.75 750 $0.98 Owners and Operators of Domestic Establishments (Electronic and Paper Submission)/Section 905(b), 905(c), 905(d) 905(h), or 905(i) of the FD&C Act...... Form FDA 3742: Listing of Ingredients (Electronic and 125 1.6 200 3 600 0.98 Paper Submissions)/Section 904(a)(1) or 904(c) of the FD&C Act.............................................. Obtaining a DUNS Number (10% of Total Respondents)..... 8 1 8 .5 (30 4 .............. minutes) ------------------------------------------------------------------------------------------------ Total.............................................. .............. ............... .............. .............. 1,354 1.96 -------------------------------------------------------------------------------------------------------------------------------------------------------- Since this collection of information was last approved by OMB on October 15, 2012, its burden has remained the same at 1,354 reporting hours. This burden estimate was determined as a result of FDA experience over the past 3 years in the regulation of tobacco products and is based on the actual number of establishment registration and product listings and product ingredient submissions received during this time period. FDA estimates that the submission of registration information as required by section 905 of the FD&C Act will remain at 3.75 hours per establishment and, based on the actual number of registration information submitted in the past 3 years and its experience, the Agency estimates that approximately 200 registrations will be submitted from 125 tobacco product establishments annually, for a total of 750 reporting burden hours. FDA estimates that the submission of ingredient listing information as required by section 904 of the FD&C Act will remain at 3 hours per tobacco product and, based on the actual number of product ingredient listings submitted over the past 3 years and its experience, the Agency estimates that approximately 200 ingredient listings will be submitted from 125 tobacco establishments, for a total of 600 reporting burden hours. FDA also estimates that obtaining a Dun and Bradstreet (DUNS) number will take 0.5 hours, and that 8 respondents (1 percent (1.25) of establishments required to register under section 905 and 5 percent (6.25) of submitters required to list ingredients under section 904) will not already have a DUNS number. The total burden is estimated to be 4 hours. Total burden hours for this collection, therefore is 1,354 hours. [[Page 22204]] Dated: April 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-09092 Filed 4-20-15; 8:45 am] BILLING CODE 4164-01-P
![22202 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
II. Selection Procedure DEPARTMENT OF HEALTH AND 1320.3(c) and includes Agency requests
HUMAN SERVICES or requirements that members of the
Any industry organization interested public submit reports, keep records, or
in participating in the selection of an Food and Drug Administration provide information to a third party.
appropriate nonvoting member to Section 3506(c)(2)(A) of the PRA (44
[Docket No. FDA–2012–N–0386]
represent industry interests should send U.S.C. 3506(c)(2)(A)) requires Federal
a letter stating that interest to the FDA Agency Information Collection Agencies to provide a 60-day notice in
contact (see FOR FURTHER INFORMATION Activities; Proposed Collection; the Federal Register concerning each
CONTACT) within 30 days of publication Comment Request; Registration and proposed collection of information,
of this document (see DATES). Within the Product Listing for Owners and including each proposed extension of an
subsequent 30 days, FDA will send a Operators of Domestic Tobacco existing collection of information,
letter to each organization that has Product Establishments and Listing of before submitting the collection to OMB
expressed an interest, attaching a Ingredients in Tobacco Products for approval. To comply with this
complete list of all such organizations; requirement, FDA is publishing notice
AGENCY: Food and Drug Administration, of the proposed collection of
and a list of all nominees along with HHS.
their current resumes. The letter will information set forth in this document.
ACTION: Notice. With respect to the following
also state that it is the responsibility of
collection of information, FDA invites
the interested organizations to confer SUMMARY: The Food and Drug comments on these topics: (1) Whether
with one another and to select a Administration (FDA) is announcing an the proposed collection of information
candidate, within 60 days after the opportunity for public comment on the is necessary for the proper performance
receipt of the FDA letter, to serve as the proposed collection of certain of FDA’s functions, including whether
nonvoting member to represent industry information by the Agency. Under the the information will have practical
interests for the committee. The Paperwork Reduction Act of 1995 (the utility; (2) the accuracy of FDA’s
interested organizations are not bound PRA), Federal Agencies are required to estimate of the burden of the proposed
by the list of nominees in selecting a publish notice in the Federal Register collection of information, including the
candidate. However, if no individual is concerning each proposed collection of validity of the methodology and
selected within 60 days, the information including each proposed assumptions used; (3) ways to enhance
Commissioner will select the nonvoting extension of an existing collection of the quality, utility, and clarity of the
member to represent industry interests. information, and to allow 60 days for information to be collected; and (4)
public comment in response to the ways to minimize the burden of the
III. Application Procedure notice. This notice solicits comments on collection of information on
the proposed extension of an existing respondents, including through the use
Individuals may self-nominate and/or collection of information pertaining to of automated collection techniques,
an organization may nominate one or registration and product listing for when appropriate, and other forms of
more individuals to serve as a nonvoting owners and operators of domestic information technology.
industry representative. Contact tobacco product establishments and
information, current curriculum vitae, listing of ingredients in tobacco Registration and Product Listing for
and the name of the committee of products. Owners and Operators of Domestic
interest should be sent to the FDA Tobacco Product Establishments and
DATES: Submit either electronic or
Advisory Committee Membership Listing of Ingredients in Tobacco
written comments on the collection of Products (OMB Control Number 0910–
Nomination Portal (see ADDRESSES) information by June 22, 2015.
within 30 days of publication of this 0650)—Extension)
ADDRESSES: Submit electronic
document (see DATES). FDA will forward comments on the collection of On June 22, 2009, the President
all nominations to the organizations information to http:// signed the Tobacco Control Act (Pub. L.
expressing interest in participating in 111–31) into law. The Tobacco Control
www.regulations.gov. Submit written
the selection process for the committee. Act amended the Federal Food, Drug,
comments on the collection of
(Persons who nominate themselves as and Cosmetic Act (the FD&C Act) (21
information to the Division of Dockets
nonvoting industry representatives will U.S.C. 301) by, among other things,
Management (HFA–305), Food and Drug
not participate in the selection process). adding a chapter granting FDA
Administration, 5630 Fishers Lane, Rm.
important authority to regulate the
FDA seeks to include the views of 1061, Rockville, MD 20852. All
manufacture, marketing, and
women, and men, members of all racial comments should be identified with the
distribution of tobacco products to
and ethnic groups and individuals with docket number found in brackets in the
protect the public health generally and
and without disabilities on its advisory heading of this document.
to reduce tobacco use by minors.
committees and, therefore encourages FOR FURTHER INFORMATION CONTACT: FDA Section 905(b) of the FD&C Act (21
nominations of appropriately qualified PRA Staff, Office of Operations, Food U.S.C. 387e(b)), as amended by the
candidates from these groups. and Drug Administration, 8455 Tobacco Control Act, requires that every
Colesville Rd., COLE–14526, Silver person who owns or operates any
This notice is issued under the Spring, MD 20993–0002, PRAStaff@
Federal Advisory Committee Act (5 establishment in any State engaged in
fda.hhs.gov. the manufacture, preparation,
U.S.C. app. 2) and 21 CFR part 14,
SUPPLEMENTARY INFORMATION: Under the compounding, or processing of a
relating to advisory committees.
tkelley on DSK3SPTVN1PROD with NOTICES
PRA (44 U.S.C. 3501–3520), Federal tobacco product or tobacco products
Dated: April 15, 2015. Agencies must obtain approval from the register with FDA the name, places of
Leslie Kux, Office of Management and Budget business, and all establishments owned
Associate Commissioner for Policy. (OMB) for each collection of or operated by that person. Every person
[FR Doc. 2015–09082 Filed 4–20–15; 8:45 am] information they conduct or sponsor. must register by December 31 of each
‘‘Collection of information’’ is defined year. Section 905(c) of the FD&C Act
BILLING CODE 4164–01–P
in 44 U.S.C. 3502(3) and 5 CFR requires that first-time persons engaging
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![22204 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices
Dated: April 15, 2015. information, refer to http:// Commitment Letter, (3) provide a period
Leslie Kux, www.fda.gov/AboutFDA/ of 30 days after the public meeting to
Associate Commissioner for Policy. WorkingatFDA/BuildingsandFacilities/ obtain written comments from the
[FR Doc. 2015–09092 Filed 4–20–15; 8:45 am] WhiteOakCampusInformation/ public, and (4) publish the comments on
BILLING CODE 4164–01–P
ucm241740.htm. the FDA Web site. This notice, the
FOR FURTHER INFORMATION CONTACT: public meeting, the 30-day comment
Connie Wisner, Center for Drug period after the meeting, and the posting
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and of the comments on the FDA Web site
HUMAN SERVICES Drug Administration, 10903 New will satisfy these requirements. The
Hampshire Ave., Bldg. 75, Rm. 1718, purpose of the public meeting is to
Food and Drug Administration Silver Spring, MD 20993, 240–402– receive public input on the
[Docket No. FDA–2012–N–0882] 7946, Connie.Wisner@fda.hhs.gov; or reauthorization of GDUFA, including
Kimberly Giordano, Center for Drug specific suggestions for changes to the
Generic Drug User Fees; Public Evaluation and Research, Food and goals referred to in the Commitment
Meeting; Request for Comments Drug Administration, 10903 New Letter. FDA is interested in responses to
Hampshire Ave., Bldg. 75, Rm. 1611, the following two general questions and
AGENCY: Food and Drug Administration, welcomes any other relevant
HHS. Silver Spring, MD 20993, 301–796–
1071, Kimberly.Giordano@fda.hhs.gov. information the public would like to
ACTION: Notice of public meeting; share:
SUPPLEMENTARY INFORMATION:
request for comments. • What is your assessment of the
I. Background overall performance of the GDUFA
SUMMARY: The Food and Drug program to date?
Administration (FDA) is announcing a On July 9, 2012, the Food and Drug
Administration Safety and Innovation • What aspects of GDUFA should be
public meeting on the Generic Drug
Act, which included GDUFA (Pub. L. retained, changed, or discontinued to
User Fee Amendments of 2012
112–144, title III), was signed into law further strengthen and improve the
(GDUFA). The legislative authority for
by the President. GDUFA authorizes program?
GDUFA expires at the end of September
2017. At that time, new legislation will FDA to collect fees from drug In general, the meeting format will
be required for FDA to continue to companies that submit marketing include presentations by FDA, scientific
collect generic drug user fees for future applications for certain generic human and academic experts, health care
fiscal years. The Federal Food, Drug, drug applications, certain drug master professionals, representatives of patient
and Cosmetic Act (the FD&C Act) files, and certain facilities. Designed to and consumer advocacy groups, the
requires that before FDA begins speed access to safe and effective generic drug industry, and the general
negotiations with the regulated industry generic drugs to the public, GDUFA public. The amount of time available for
on GDUFA reauthorization; we publish requires that generic drug manufacturers public testimony will be determined by
a notice in the Federal Register pay user fees to finance critical and the number of persons who register to
requesting public input on the measurable generic drug program present at the meeting. A draft agenda
reauthorization, hold a public meeting enhancements. GDUFA also requires and other background information for
at which the public may present its that generic drug facilities around the the public meeting will be posted at
views on the reauthorization, including world provide identification http://www.fda.gov/gdufa by June 8,
specific suggestions for changes to the information annually to FDA. 2015.
goals referred to in the Generic Drug Additional information concerning III. Meeting Attendance and
User Fee Act Program Performance GDUFA, including the text of the law, Participation
Goals and Procedures (i.e., the the Commitment Letter, key Federal
Commitment Letter), provide a period of Register documents, GDUFA-related FDA is seeking participation (i.e.,
30 days after the public meeting to guidances, performance reports, and attendance and oral presentations) at the
obtain written comments from the financial reports may be found on the public meeting by all interested parties,
public, and publish the comments on FDA Web site at http://www.fda.gov/ including but not limited to scientific
FDA’s Web site. FDA invites public gdufa. and academic experts, health care
comment on the GDUFA program and professionals, representatives of patient
II. Purpose of Public Meeting and consumer advocacy groups, the
suggestions regarding the features FDA
should propose for the next GDUFA FDA is announcing a public meeting generic drug industry, and the general
program. on GDUFA. The authority for GDUFA public. If you wish to attend the
expires at the end of September 2017. meeting, please email your registration
DATES: The public meeting will be held Without new legislation, FDA will no information to GenericDrugPolicy@
on June 15, 2015, from 9 a.m. to 5 p.m. longer be able to collect user fees to fda.hhs.gov by June 1, 2015. Your email
The public meeting may be extended or fund the human generic drug review should contain complete contact
may end early depending on the level of process. Section 744(C)(d)(2) (21 U.S.C. information for each attendee, including
public participation. 379j–43(d)(2)) of the FD&C Act requires name, title, affiliation, address, email
ADDRESSES: The public meeting will be that before FDA begins negotiations address, and telephone number.
held at the FDA White Oak Campus, with the regulated industry on GDUFA Registration is free and is on a first-
10903 New Hampshire Ave., Bldg. 31 reauthorization, we do the following: (1) come, first-served basis. Early
tkelley on DSK3SPTVN1PROD with NOTICES
Conference Center, the Great Room (Rm. Publish a notice in the Federal Register registration is recommended because
1503), Silver Spring, MD 20993–0002. requesting public input on the seating is limited. Registrants will
Entrance for the public meeting reauthorization, (2) hold a public receive confirmation once they have
participants (non-FDA employees) is meeting at which the public may been accepted. If registration becomes
through Building 1, where routine present its views on the reauthorization, full prior to the meeting, FDA will place
security check procedures will be including specific suggestions for a notice on http://www.fda.gov/gdufa.
performed. For parking and security changes to the goals referred to in the Onsite registration on the day of the
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Document Created: 2015-12-16 08:33:49
Document Modified: 2015-12-16 08:33:49
| 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 | Submit either electronic or written comments on the collection of information by June 22, 2015. | |
| 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 | 80 FR 22202 |
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