80_FR_22278 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

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)

Page Range22202-22204
FR Document2015-09092

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.

Federal Register, Volume 80 Issue 76 (Tuesday, April 21, 2015)
[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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                                                                                      Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices                                                                                          22203

                                              in the manufacture, preparation,                                        of advertisements. Section 904(a)(1) of                                      to FDA under the Tobacco Control Act.
                                              compounding, or processing of a                                         the FD&C Act (21 U.S.C. 387d(a)(1)), as                                      While electronic submission of
                                              tobacco product or tobacco products                                     amended by the Tobacco Control Act,                                          registration and product listing
                                              shall register with the Secretary the                                   requires each tobacco product                                                information and ingredient listing
                                              name, places of business, and all such                                  manufacturer or importer, or agent                                           information are not required, FDA is
                                              establishments of that person. Section                                  thereof, to submit a listing of all                                          strongly encouraging electronic
                                              905(d) states that persons required to                                  ingredients, including tobacco,                                              submission to facilitate efficiency and
                                              register under section 905(b) or 905(c) of                              substances, compounds, and additives                                         timeliness of data management and
                                              the FD&C Act shall register any                                         that are added by the manufacturer to                                        collection. To that end, FDA designed
                                              additional establishment that they own                                  the tobacco, paper, filter, or other part                                    electronic submission applications to
                                              or operate in any state which begins the                                of each tobacco product by brand or by                                       streamline the data entry process for
                                              manufacture, preparation,                                               quantity in each brand and sub-brand.                                        registration and product listing and for
                                              compounding, or processing of a                                         Since the Tobacco Control Act was                                            ingredient listing. These tools allow for
                                              tobacco product or tobacco products.                                    enacted on June 22, 2009, the                                                importation of large quantities of
                                              Section 905(h) of the FD&C Act                                          information required under section                                           structured data, attachment of files (e.g.,
                                              addresses foreign establishment                                         904(a)(1) of the FD&C Act must be                                            in PDFs and certain media files), and
                                              registration requirements, which will go                                submitted to FDA by December 22,                                             automatic acknowledgement of FDA’s
                                              into effect when regulations are                                        2009, and include the ingredients added                                      receipt of submissions.
                                              promulgated by the Secretary. Section                                   as of the date of submission. Section                                           FDA also developed paper forms
                                              905(i)(1) of the FD&C Act, as amended                                   904(c) of the FD&C Act also requires                                         (Form FDA 3741—Registration and
                                              by the Tobacco Control Act, requires                                    submission of information whenever                                           Listing for Owners and Operators of
                                              that all registrants shall, at the time of                              additives, or the quantities of additives,                                   Domestic Tobacco Product
                                              registration under any such subsection,                                 are changed.                                                                 Establishments, and Form FDA 3742—
                                              file with FDA a list of all tobacco                                       FDA issued guidance documents on                                           Listing of Ingredients in Tobacco
                                              products which are being manufactured,                                  both: (1) ‘‘Registration and Product                                         Products) as an alternative submission
                                              prepared, compounded, or processed by                                   Listing for Owners and Operators of                                          tool. Both the electronic submission
                                              that person for commercial distribution,                                Domestic Tobacco Product                                                     application and the paper forms can be
                                              along with certain accompanying                                         Establishments’’ and (2) ‘‘Listing of                                        accessed at http://www.fda.gov/tobacco.
                                              consumer information, such as all                                       Ingredients in Tobacco Products’’ to                                         FDA estimates the burden of this
                                              labeling and a representative sampling                                  assist persons making such submissions                                       collection of information as follows:

                                                                                                            TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
                                                                                                                                          Number of                                                 Average                                 Total operating
                                                                                                               Number of                                             Total annual
                                                                     Activity                                                           responses per                                             burden per              Total hours        and mainte-
                                                                                                              respondents                                             responses
                                                                                                                                          respondent                                               response                                  nance costs

                                              Form FDA 3741: Registration and Prod-
                                                uct Listing for Owners and Operators
                                                of Domestic Establishments (Elec-
                                                tronic and Paper Submission)/Section
                                                905(b), 905(c), 905(d) 905(h), or
                                                905(i) of the FD&C Act .......................                                125                           1.6                       200                       3.75               750                     $0.98
                                              Form FDA 3742: Listing of Ingredients
                                                (Electronic and Paper Submissions)/
                                                Section 904(a)(1) or 904(c) of the
                                                FD&C Act ...........................................                          125                           1.6                       200                            3             600                       0.98
                                              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                                  number of registration information                                           will be submitted from 125 tobacco
                                              was last approved by OMB on October                                     submitted in the past 3 years and its                                        establishments, for a total of 600
                                              15, 2012, its burden has remained the                                   experience, the Agency estimates that                                        reporting burden hours.
                                              same at 1,354 reporting hours. This                                     approximately 200 registrations will be                                        FDA also estimates that obtaining a
                                              burden estimate was determined as a                                     submitted from 125 tobacco product                                           Dun and Bradstreet (DUNS) number will
                                              result of FDA experience over the past                                  establishments annually, for a total of                                      take 0.5 hours, and that 8 respondents
                                              3 years in the regulation of tobacco                                    750 reporting burden hours. FDA                                              (1 percent (1.25) of establishments
                                              products and is based on the actual                                     estimates that the submission of                                             required to register under section 905
                                              number of establishment registration                                    ingredient listing information as                                            and 5 percent (6.25) of submitters
tkelley on DSK3SPTVN1PROD with NOTICES




                                              and product listings and product                                        required by section 904 of the FD&C Act                                      required to list ingredients under
                                              ingredient submissions received during                                  will remain at 3 hours per tobacco                                           section 904) will not already have a
                                              this time period. FDA estimates that the                                product and, based on the actual
                                                                                                                                                                                                   DUNS number. The total burden is
                                              submission of registration information                                  number of product ingredient listings
                                                                                                                                                                                                   estimated to be 4 hours. Total burden
                                              as required by section 905 of the FD&C                                  submitted over the past 3 years and its
                                                                                                                                                                                                   hours for this collection, therefore is
                                              Act will remain at 3.75 hours per                                       experience, the Agency estimates that
                                                                                                                                                                                                   1,354 hours.
                                              establishment and, based on the actual                                  approximately 200 ingredient listings


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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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by June 22, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 22202 

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