80_FR_48477 80 FR 48322 - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration

80 FR 48322 - Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 155 (August 12, 2015)

Page Range48322-48324
FR Document2015-19741

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our 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. This notice solicits comments on the information collection provisions of the recommended labeling of certain beers subject to our labeling jurisdiction.

Federal Register, Volume 80 Issue 155 (Wednesday, August 12, 2015)
[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48322-48324]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19741]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Labeling of Certain Beers Subject to the Labeling 
Jurisdiction of the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on our 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. This notice 
solicits comments on the information collection provisions of the 
recommended labeling of certain beers subject to our labeling 
jurisdiction.

DATES: Submit either electronic or written comments on the collection 
of information by October 13, 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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.

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the 
Food and Drug Administration--(OMB Control Number 0910-0728)--Extension

    The definition of ``food'' under section 201(f) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) See 21 U.S.C. 321(f), 
includes ``articles used for food or drink'' and thus includes 
alcoholic beverages. As such, alcoholic beverages are subject to the 
FD&C Act's adulteration and misbranding provisions, and implementing 
regulations, related to food. For example, manufacturers of alcoholic 
beverages are responsible for adhering to the registration of food 
facilities requirements in 21 CFR part 1 and to the good manufacturing 
practice regulations in 21 CFR part 110. There are also certain 
requirements for nutrition labeling on menus, menu boards, and other 
written materials for alcohol beverages served in restaurants or 
similar retail food establishments in 21 CFR part 101 (79 FR 71156, 
December 1, 2014). However, as reflected in a 1987 Memorandum of 
Understanding between FDA and the Alcohol and Tobacco Tax and Trade 
Bureau (TTB), TTB is responsible for the promulgation and enforcement 
of regulations with respect to the labeling of distilled spirits, 
certain wines, and malt beverages pursuant to the Federal Alcohol 
Administration Act (FAA Act). In TTB Ruling 2008-3, dated July 7, 2008, 
TTB clarified that certain beers, which are not made from both malted 
barley and hops but are instead made from substitutes for malted barley 
(such as sorghum, rice, or wheat) or are made without hops, do not meet 
the definition of a ``malt beverage'' under the FAA Act. Accordingly, 
TTB stated in its ruling that such products (other than sake, which is 
classified as a wine under the FAA Act), are not subject to the 
labeling, advertising, or other provisions of the TTB regulations 
promulgated under the FAA Act.
    In cases where an alcoholic beverage is not covered by the labeling 
provisions of the FAA Act, the product is subject to ingredient and 
other labeling requirements under the FD&C Act and the implementing 
regulations that we administer. In addition, as provided for

[[Page 48323]]

under the Fair Packaging and Labeling Act (FPLA), alcoholic beverages 
that are not covered by the labeling provisions of the FAA Act are 
subject to the provisions of the FPLA, which we administer.
    Therefore, the beers described in the TTB's Ruling as not being a 
``malt beverage'' are subject to the labeling requirements under the 
FD&C Act and FPLA, and our implementing regulations. In general, we 
require that food products under our jurisdiction be truthfully and 
informatively labeled in accordance with the FD&C Act, the FPLA, and 
FDA's regulations. Furthermore, some TTB labeling requirements, such as 
the Government Health Warning Statement under the Alcoholic Beverage 
Labeling Act and certain marking requirements under the Internal 
Revenue Code, continue to apply to these products.
    In the Federal Register of December 23, 2014 (79 FR 77013), we 
announced the availability of a guidance entitled, ``Labeling of 
Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug 
Administration''. Persons with access to the Internet may obtain the 
guidance at http://www.fda.gov/FoodGuidances. This guidance is intended 
to assist manufacturers on how to label bottled or otherwise packaged 
beers that are subject to our labeling laws and regulations.
    Our food labeling regulations under parts 101, 102, 104, and 105 
(21 CFR parts 101, 102, 104, and 105) were issued under the authority 
of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455) 
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the 
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most 
of these regulations derive from section 403 of the FD&C Act, which 
provides that a food product shall be deemed to be misbranded if, among 
other things, its label or labeling fails to bear certain required 
information concerning the food product, is false or misleading in any 
particular, or bears certain types of unauthorized claims. The 
disclosure requirements and other collections of information in the 
regulations in parts 101, 102, 104, and 105 are necessary to ensure 
that food products produced or sold in the United States are in 
compliance with the labeling provisions of the FD&C Act and the FPLA.
    The primary user of the information to be disclosed on the label or 
labeling of food products is the consumer that purchases the food 
product. Consumers will use the information to assist them in making 
choices concerning their purchase of a food product, including choices 
related to substances that the consumer must avoid to prevent adverse 
reactions. This information also enables the consumer to determine the 
role of the food product in a healthful diet. Additionally, FDA intends 
to use the information to determine whether a manufacturer or other 
supplier of food products is meeting its statutory and regulatory 
obligations. Failure of a manufacturer or other supplier of food 
products to label its products in compliance with section 403 of the 
FD& C Act and parts 101, 102, 104, and 105 of FDA's food labeling 
regulations may result in a product being misbranded under the FD&C 
Act, subjecting the firm and product to regulatory action.
    Description of respondents: The respondents to this collection of 
information are manufacturers of beers that are subject to our labeling 
laws and regulations.
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                   Number of      disclosures    Total annual    Average burden
           Citation               respondents         per         disclosures    per disclosure     Total hours
                                                  respondent
----------------------------------------------------------------------------------------------------------------
21 CFR 101.3 and 101.22.......              12               2              24  0.5 (30 minutes)              12
21 CFR 101.4..................              12               2              24  1...............              24
21 CFR 101.5..................              12               2              24  0.25 (15                       6
                                                                                 minutes).
21 CFR 101.9..................              12               2              24  4...............              96
21 CFR 101.105................              12               2              24  0.5 (30 minutes)              12
Section 403(w)(1) of the FD&C               12               2              24  1...............              24
 Act.
Guidance document entitled                  12               1              12  1...............              12
 ``Labeling of Certain Beers
 Subject to the Labeling
 Jurisdiction of the Food and
 Drug Administration''.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             186
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate of the number of respondents in table 1 is based on 
the number of regulatory submissions submitted to TTB for beers that do 
not meet the definition of a ``malt beverage'' under the FAA Act. Based 
on its records of submissions received from manufacturers of such 
products, TTB estimates the number of respondents to be 12 and the 
number of disclosures annually to be 24. Thus, we adopt TTB's estimate 
of 12 respondents, and an annual number of disclosures per respondent 
of 2, in table 1 of this document.
    Our estimates of the average burden per disclosure for each 
regulation are based on our experience with food labeling under the 
Agency's jurisdiction. The estimated average burden per disclosure for 
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 in table 1 
are equal to, and based upon, the estimated average burden per 
disclosure approved by OMB in OMB control number 0910-0381. We further 
estimate that the labeling burden of section 403(w)(1) of the FD&C Act, 
which specifies requirements for the declaration of food allergens, 
will be 1 hour based upon the similarity of the requirements to that of 
Sec.  101.4. Finally, FDA estimates that a respondent will spend 1 hour 
reading the guidance document.
    Thus, we estimate that 12 respondents will each label 2 products 
annually, for a total of 24 labels. We estimate that the manufacturers 
will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4 hours + 0.5 
hour + 1 hour = 7.25 hours) on each label to comply with our labeling 
regulations and the requirements of section 403(w)(1) of the FD&C Act, 
for a total of 174 hours (24

[[Page 48324]]

labels x 7.25 hours = 174 hours). In addition, 12 respondents will each 
spend 1 hour reading the guidance document, for a total of 12 hours. 
Thus, we estimate the total hour burden of the proposed collection of 
information to be 186 hours (174 hours + 12 hours = 186 hours).
    The guidance also refers to previously approved collections of 
information found in our regulations. The collections of information in 
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been 
approved under OMB control number 0910-0381. Allergen labeling of these 
beers under section 403(w)(1) of the FD&C Act, which was added by the 
Food Allergen Labeling and Consumer Protection Act of 2004, has been 
approved under OMB control number 0910-0792.

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19741 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                  48322                      Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices

                                                  the following proposed collection(s) of                 comment on our proposed collection of                 information, including the validity of
                                                  information for public comment:                         certain information by the Agency.                    the methodology and assumptions used;
                                                    1. Type of Information Collection                     Under the Paperwork Reduction Act of                  (3) ways to enhance the quality, utility,
                                                  Request: Revision of a currently                        1995 (the PRA), Federal Agencies are                  and clarity of the information to be
                                                  approved collection; Title of                           required to publish notice in the                     collected; and (4) ways to minimize the
                                                  Information Collection: Skilled Nursing                 Federal Register concerning each                      burden of the collection of information
                                                  Facility and Skilled Nursing Facility                   proposed collection of information,                   on respondents, including through the
                                                  Health Care Complex Cost Report Form;                   including each proposed extension of an               use of automated collection techniques,
                                                  Use: Providers of services participating                existing collection of information, and               when appropriate, and other forms of
                                                  in the Medicare program are required                    to allow 60 days for public comment.                  information technology.
                                                  under sections 1815(a), 1833(e) and                     This notice solicits comments on the
                                                  1861(v)(1)(A) of the Social Security Act                                                                      Labeling of Certain Beers Subject to the
                                                                                                          information collection provisions of the
                                                  (42 U.S.C. 1395g) to submit annual                                                                            Labeling Jurisdiction of the Food and
                                                                                                          recommended labeling of certain beers
                                                  information to achieve settlement of                                                                          Drug Administration—(OMB Control
                                                                                                          subject to our labeling jurisdiction.
                                                  costs for health care services rendered to                                                                    Number 0910–0728)—Extension
                                                                                                          DATES: Submit either electronic or
                                                  Medicare beneficiaries. In addition,                    written comments on the collection of                    The definition of ‘‘food’’ under
                                                  regulations at 42 CFR 413.20 and 413.24                 information by October 13, 2015.                      section 201(f) of the Federal Food, Drug,
                                                  require adequate cost data and cost                     ADDRESSES: Submit electronic
                                                                                                                                                                and Cosmetic Act (the FD&C Act) See 21
                                                  reports from providers on an annual                     comments on the collection of                         U.S.C. 321(f), includes ‘‘articles used for
                                                  basis. The Form CMS–2540–10 cost                        information to http://                                food or drink’’ and thus includes
                                                  report is needed to determine a                         www.regulations.gov. Submit written                   alcoholic beverages. As such, alcoholic
                                                  provider’s reasonable cost incurred in                  comments on the collection of                         beverages are subject to the FD&C Act’s
                                                  furnishing medical services to Medicare                 information to the Division of Dockets                adulteration and misbranding
                                                  beneficiaries and reimbursement due to                  Management (HFA–305), Food and Drug                   provisions, and implementing
                                                  or from a provider. The revisions made                  Administration, 5630 Fishers Lane, Rm.                regulations, related to food. For
                                                  to the SNF cost report are in accordance                1061, Rockville, MD 20852. All                        example, manufacturers of alcoholic
                                                  with the statutory requirement for                      comments should be identified with the                beverages are responsible for adhering
                                                  hospice payment reform in § 3132 of the                 docket number found in brackets in the                to the registration of food facilities
                                                  Patient Protection and Affordable Care                  heading of this document.                             requirements in 21 CFR part 1 and to
                                                  Act (ACA). Form Number: CMS–2540–                                                                             the good manufacturing practice
                                                                                                          FOR FURTHER INFORMATION CONTACT: FDA
                                                  10 (OMB control number 0938–0463);                                                                            regulations in 21 CFR part 110. There
                                                                                                          PRA Staff, Office of Operations, Food                 are also certain requirements for
                                                  Frequency: Annually; Affected Public:                   and Drug Administration, 8455
                                                  Private sector (Business or other for-                                                                        nutrition labeling on menus, menu
                                                                                                          Colesville Rd., COLE–14526, Silver                    boards, and other written materials for
                                                  profits and Not-for-profit institutions);               Spring, MD 20993–0002, PRAStaff@
                                                  Number of Respondents: 14,398; Total                                                                          alcohol beverages served in restaurants
                                                                                                          fda.hhs.gov.                                          or similar retail food establishments in
                                                  Annual Responses: 14,398; Total
                                                  Annual Hours: 2,908,396. (For policy                    SUPPLEMENTARY INFORMATION: Under the                  21 CFR part 101 (79 FR 71156,
                                                  questions regarding this collection                     PRA (44 U.S.C. 3501–3520), Federal                    December 1, 2014). However, as
                                                  contact Amelia Citerone at 410–786–                     Agencies must obtain approval from the                reflected in a 1987 Memorandum of
                                                  8008).                                                  Office of Management and Budget                       Understanding between FDA and the
                                                                                                          (OMB) for each collection of                          Alcohol and Tobacco Tax and Trade
                                                     Dated: August 7, 2015.                               information they conduct or sponsor.                  Bureau (TTB), TTB is responsible for the
                                                  William N. Parham, III,                                 ‘‘Collection of information’’ is defined              promulgation and enforcement of
                                                  Director, Paperwork Reduction Staff, Office             in 44 U.S.C. 3502(3) and 5 CFR                        regulations with respect to the labeling
                                                  of Strategic Operations and Regulatory                  1320.3(c) and includes Agency requests                of distilled spirits, certain wines, and
                                                  Affairs.                                                or requirements that members of the                   malt beverages pursuant to the Federal
                                                  [FR Doc. 2015–19837 Filed 8–11–15; 8:45 am]             public submit reports, keep records, or               Alcohol Administration Act (FAA Act).
                                                  BILLING CODE 4120–01–P                                  provide information to a third party.                 In TTB Ruling 2008–3, dated July 7,
                                                                                                          Section 3506(c)(2)(A) of the PRA (44                  2008, TTB clarified that certain beers,
                                                                                                          U.S.C. 3506(c)(2)(A)) requires Federal                which are not made from both malted
                                                  DEPARTMENT OF HEALTH AND                                Agencies to provide a 60-day notice in                barley and hops but are instead made
                                                  HUMAN SERVICES                                          the Federal Register concerning each                  from substitutes for malted barley (such
                                                  Food and Drug Administration                            proposed collection of information,                   as sorghum, rice, or wheat) or are made
                                                                                                          including each proposed extension of an               without hops, do not meet the definition
                                                  [Docket No. FDA–2009–D–0268]                            existing collection of information,                   of a ‘‘malt beverage’’ under the FAA
                                                                                                          before submitting the collection to OMB               Act. Accordingly, TTB stated in its
                                                  Agency Information Collection                           for approval. To comply with this                     ruling that such products (other than
                                                  Activities; Proposed Collection;                        requirement, we are publishing notice of              sake, which is classified as a wine under
                                                  Comment Request; Labeling of Certain                    the proposed collection of information                the FAA Act), are not subject to the
                                                  Beers Subject to the Labeling                           set forth in this document.                           labeling, advertising, or other provisions
                                                  Jurisdiction of the Food and Drug                          With respect to the following                      of the TTB regulations promulgated
                                                  Administration
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                                                                                                          collection of information, we invite                  under the FAA Act.
                                                  AGENCY:    Food and Drug Administration,                comments on these topics: (1) Whether                    In cases where an alcoholic beverage
                                                  HHS.                                                    the proposed collection of information                is not covered by the labeling provisions
                                                  ACTION:   Notice.                                       is necessary for the proper performance               of the FAA Act, the product is subject
                                                                                                          of our functions, including whether the               to ingredient and other labeling
                                                  SUMMARY: The Food and Drug                              information will have practical utility;              requirements under the FD&C Act and
                                                  Administration (FDA or we) is                           (2) the accuracy of our estimate of the               the implementing regulations that we
                                                  announcing an opportunity for public                    burden of the proposed collection of                  administer. In addition, as provided for


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                                                                                    Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices                                                                                                48323

                                                  under the Fair Packaging and Labeling                                   intended to assist manufacturers on how                                      purchases the food product. Consumers
                                                  Act (FPLA), alcoholic beverages that are                                to label bottled or otherwise packaged                                       will use the information to assist them
                                                  not covered by the labeling provisions                                  beers that are subject to our labeling                                       in making choices concerning their
                                                  of the FAA Act are subject to the                                       laws and regulations.                                                        purchase of a food product, including
                                                  provisions of the FPLA, which we                                           Our food labeling regulations under                                       choices related to substances that the
                                                  administer.                                                             parts 101, 102, 104, and 105 (21 CFR                                         consumer must avoid to prevent adverse
                                                     Therefore, the beers described in the                                parts 101, 102, 104, and 105) were                                           reactions. This information also enables
                                                  TTB’s Ruling as not being a ‘‘malt                                      issued under the authority of sections 4,                                    the consumer to determine the role of
                                                  beverage’’ are subject to the labeling                                  5, and 6 of the FPLA (15 U.S.C. 1453,
                                                                                                                                                                                                       the food product in a healthful diet.
                                                  requirements under the FD&C Act and                                     1454, and 1455) and under sections 201,
                                                                                                                                                                                                       Additionally, FDA intends to use the
                                                  FPLA, and our implementing                                              301, 402, 403, 409, 411, 701, and 721 of
                                                  regulations. In general, we require that                                the FD&C Act (21 U.S.C. 321, 331, 342,                                       information to determine whether a
                                                  food products under our jurisdiction be                                 343, 348, 350, 371, and 379e). Most of                                       manufacturer or other supplier of food
                                                  truthfully and informatively labeled in                                 these regulations derive from section                                        products is meeting its statutory and
                                                  accordance with the FD&C Act, the                                       403 of the FD&C Act, which provides                                          regulatory obligations. Failure of a
                                                  FPLA, and FDA’s regulations.                                            that a food product shall be deemed to                                       manufacturer or other supplier of food
                                                  Furthermore, some TTB labeling                                          be misbranded if, among other things,                                        products to label its products in
                                                  requirements, such as the Government                                    its label or labeling fails to bear certain                                  compliance with section 403 of the FD&
                                                  Health Warning Statement under the                                      required information concerning the                                          C Act and parts 101, 102, 104, and 105
                                                  Alcoholic Beverage Labeling Act and                                     food product, is false or misleading in                                      of FDA’s food labeling regulations may
                                                  certain marking requirements under the                                  any particular, or bears certain types of                                    result in a product being misbranded
                                                  Internal Revenue Code, continue to                                      unauthorized claims. The disclosure                                          under the FD&C Act, subjecting the firm
                                                  apply to these products.                                                requirements and other collections of                                        and product to regulatory action.
                                                     In the Federal Register of December                                  information in the regulations in parts
                                                                                                                                                                                                         Description of respondents: The
                                                  23, 2014 (79 FR 77013), we announced                                    101, 102, 104, and 105 are necessary to
                                                  the availability of a guidance entitled,                                                                                                             respondents to this collection of
                                                                                                                          ensure that food products produced or
                                                  ‘‘Labeling of Certain Beers Subject to the                                                                                                           information are manufacturers of beers
                                                                                                                          sold in the United States are in
                                                  Labeling Jurisdiction of the Food and                                   compliance with the labeling provisions                                      that are subject to our labeling laws and
                                                  Drug Administration’’. Persons with                                     of the FD&C Act and the FPLA.                                                regulations.
                                                  access to the Internet may obtain the                                      The primary user of the information                                         We estimate the burden of this
                                                  guidance at http://www.fda.gov/                                         to be disclosed on the label or labeling                                     collection of information as follows:
                                                  FoodGuidances. This guidance is                                         of food products is the consumer that

                                                                                                TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
                                                                                                                                        Number of
                                                                                                             Number of                  disclosures               Total annual
                                                                      Citation                                                                                                                  Average burden per disclosure                             Total hours
                                                                                                            respondents                     per                   disclosures
                                                                                                                                        respondent

                                                  21 CFR 101.3 and 101.22 ................                                     12                          2                        24      0.5 (30 minutes) ...............................                        12
                                                  21 CFR 101.4 ...................................                             12                          2                        24      1 .......................................................               24
                                                  21 CFR 101.5 ...................................                             12                          2                        24      0.25 (15 minutes) .............................                          6
                                                  21 CFR 101.9 ...................................                             12                          2                        24      4 .......................................................               96
                                                  21 CFR 101.105 ...............................                               12                          2                        24      0.5 (30 minutes) ...............................                        12
                                                  Section 403(w)(1) of the FD&C Act ..                                         12                          2                        24      1 .......................................................               24
                                                  Guidance document entitled ‘‘Label-                                          12                          1                        12      1 .......................................................               12
                                                    ing of Certain Beers Subject to the
                                                    Labeling Jurisdiction of the Food
                                                    and Drug Administration’’.

                                                       Total ...........................................   ........................   ........................   ........................   ...........................................................            186
                                                     1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    Our estimate of the number of                                           Our estimates of the average burden                                        hour based upon the similarity of the
                                                  respondents in table 1 is based on the                                  per disclosure for each regulation are                                       requirements to that of § 101.4. Finally,
                                                  number of regulatory submissions                                        based on our experience with food                                            FDA estimates that a respondent will
                                                  submitted to TTB for beers that do not                                  labeling under the Agency’s                                                  spend 1 hour reading the guidance
                                                  meet the definition of a ‘‘malt beverage’’                              jurisdiction. The estimated average                                          document.
                                                  under the FAA Act. Based on its records                                 burden per disclosure for §§ 101.3,                                             Thus, we estimate that 12 respondents
                                                  of submissions received from                                            101.4, 101.5, 101.9, 101.22, and 101.105                                     will each label 2 products annually, for
                                                  manufacturers of such products, TTB                                     in table 1 are equal to, and based upon,                                     a total of 24 labels. We estimate that the
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                                                  estimates the number of respondents to                                  the estimated average burden per                                             manufacturers will spend 7.25 hours
                                                  be 12 and the number of disclosures                                     disclosure approved by OMB in OMB                                            (0.5 hours + 1 hour + 0.25 hour + 4
                                                  annually to be 24. Thus, we adopt TTB’s                                 control number 0910–0381. We further                                         hours + 0.5 hour + 1 hour = 7.25 hours)
                                                  estimate of 12 respondents, and an                                      estimate that the labeling burden of                                         on each label to comply with our
                                                  annual number of disclosures per                                        section 403(w)(1) of the FD&C Act,                                           labeling regulations and the
                                                  respondent of 2, in table 1 of this                                     which specifies requirements for the                                         requirements of section 403(w)(1) of the
                                                  document.                                                               declaration of food allergens, will be 1                                     FD&C Act, for a total of 174 hours (24


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                                                  48324                      Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices

                                                  labels × 7.25 hours = 174 hours). In                    4th Floor, Silver Spring, MD 20993–                   that fees paid pursuant to sections 503B
                                                  addition, 12 respondents will each                      0002. Send one self-addressed adhesive                and 744K of the FD&C Act will not be
                                                  spend 1 hour reading the guidance                       label to assist that office in processing             refunded, FDA is issuing this guidance
                                                  document, for a total of 12 hours. Thus,                your requests. See the SUPPLEMENTARY                  to answer some of these questions and
                                                  we estimate the total hour burden of the                INFORMATION section for electronic                    to provide potential registrants
                                                  proposed collection of information to be                access to the guidance document.                      additional information about the
                                                  186 hours (174 hours + 12 hours = 186                     Submit electronic comments on the                   regulatory impact of registering as an
                                                  hours).                                                 guidance to http://www.regulations.gov.               outsourcing facility.
                                                    The guidance also refers to previously                Submit written comments to the                           In the Federal Register of February
                                                  approved collections of information                     Division of Dockets Management (HFA–                  19, 2015 (80 FR 8871), FDA issued a
                                                  found in our regulations. The                           305), Food and Drug Administration,                   notice announcing the availability of the
                                                  collections of information in §§ 101.3,                 5630 Fishers Lane, Rm. 1061, Rockville,               draft version of this guidance. The
                                                  101.4, 101.5, 101.9, 101.22, and 101.105                MD 20852.                                             comment period on the draft guidance
                                                  have been approved under OMB control                    FOR FURTHER INFORMATION CONTACT: Sara                 ended on May 20, 2015. FDA received
                                                  number 0910–0381. Allergen labeling of                  Rothman, Food and Drug                                eleven comments on the draft guidance.
                                                  these beers under section 403(w)(1) of                  Administration, 10903 New Hampshire                   Some of the comments raised issues that
                                                  the FD&C Act, which was added by the                    Ave., Silver Spring, MD 20993, 301–                   were not directly pertinent to the topics
                                                  Food Allergen Labeling and Consumer                     796–3110.                                             addressed in this guidance. FDA intends
                                                  Protection Act of 2004, has been                                                                              to consider those comments as they
                                                                                                          SUPPLEMENTARY INFORMATION:
                                                  approved under OMB control number                                                                             relate to issues being addressed in other
                                                  0910–0792.                                              I. Background                                         policy documents being developed by
                                                                                                                                                                the Agency.
                                                    Dated: August 6, 2015.                                   FDA is announcing the availability of                 In response to received comments or
                                                  Leslie Kux,                                             a final guidance for industry entitled                on its own initiative, FDA made the
                                                  Associate Commissioner for Policy.                      ‘‘Guidance for Entities Considering                   following changes as it finalized this
                                                  [FR Doc. 2015–19741 Filed 8–11–15; 8:45 am]             Whether to Register as Outsourcing                    guidance: (1) Removed the reference to
                                                  BILLING CODE 4164–01–P
                                                                                                          Facilities Under Section 503B of the                  a separate guidance document that
                                                                                                          Federal Food, Drug, and Cosmetic Act.’’               explains how outsourcing facilities
                                                                                                          On November 27, 2013, President                       should report the products they
                                                  DEPARTMENT OF HEALTH AND                                Obama signed the DQSA (Pub. L. 113–                   compound to FDA because that
                                                  HUMAN SERVICES                                          54) into law. The DQSA added a new                    guidance is not directly related to the
                                                                                                          section 503B to the FD&C Act that                     issue of entities considering whether to
                                                  Food and Drug Administration                            created a category of entities called                 register as outsourcing facilities; (2)
                                                                                                          ‘‘outsourcing facilities.’’ Section                   noted that FDA has issued separate
                                                  [Docket No. FDA–2014–D–1399]
                                                                                                          503B(d)(4) of the FD&C Act (21 U.S.C.                 guidance documents addressing some of
                                                  Guidance for Entities Considering                       353b(d)(4)) defines an outsourcing                    the conditions of section 503B and that
                                                  Whether To Register as Outsourcing                      facility, in part, as a facility that                 it intends to publish additional
                                                  Facilities Under Section 503B of the                    complies with all of the requirements of              guidance addressing other conditions;
                                                  Federal Food, Drug, and Cosmetic Act;                   section 503B, including registering with              (3) added a reference to FDA’s draft
                                                  Guidance for Industry; Availability                     FDA as an outsourcing facility and                    guidance regarding compounding
                                                                                                          paying associated fees. If the conditions             animal drug products from bulk drug
                                                  AGENCY:    Food and Drug Administration,                outlined in section 503B(a) of the FD&C               substances, which addresses
                                                  HHS.                                                    Act are satisfied, a drug compounded by               outsourcing facilities engaging in this
                                                  ACTION:   Notice.                                       or under the direct supervision of a                  activity; and (4) made grammatical and
                                                                                                          licensed pharmacist in an outsourcing                 other minor editorial changes for clarity.
                                                  SUMMARY:    The Food and Drug                           facility is exempt from certain sections                 This guidance is being issued
                                                  Administration (FDA) is announcing the                  of the FD&C Act, including section                    consistent with FDA’s good guidance
                                                  availability of a final guidance entitled               502(f)(1) (21 U.S.C. 352(f)(1))                       practices regulation (21 CFR 10.115).
                                                  ‘‘Guidance for Entities Considering                     (concerning the labeling of drugs with                The guidance represents the Agency’s
                                                  Whether to Register as Outsourcing                      adequate directions for use) and section              current thinking on registering as an
                                                  Facilities Under Section 503B of the                    505 (21 U.S.C. 355) (concerning the                   outsourcing facility under section 503B
                                                  Federal Food, Drug, and Cosmetic Act.’’                 approval of human drug products under                 of the FD&C Act. It does not create any
                                                  This guidance is intended to inform                     new drug applications (NDAs) or                       rights for any person and is not binding
                                                  entities that are considering registering               abbreviated new drug applications                     on FDA or the public. You can use an
                                                  as outsourcing facilities under section                 (ANDAs)). Drugs compounded in                         alternative approach if it satisfies the
                                                  503B of the Federal Food, Drug, and                     outsourcing facilities are not exempt                 requirements of the applicable statutes
                                                  Cosmetic Act (the FD&C Act), as added                   from the requirements of section                      and regulations.
                                                  by the Drug Quality and Security Act                    501(a)(2)(B) of the FD&C Act (21 U.S.C.
                                                  (DQSA), of the regulatory implications                  351(a)(2)(B)) (concerning current good                II. Comments
                                                  of registration as an outsourcing facility.             manufacturing practice for drugs).                       Interested persons may submit either
                                                  DATES: Submit either electronic or                         FDA has received questions about                   electronic comments regarding this
                                                  written comments on Agency guidances
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          whether entities engaged in various                   document to http://www.regulations.gov
                                                  at any time.                                            types of activities (e.g., a facility that is         or written comments to the Division of
                                                  ADDRESSES: Submit written requests for                  compounding only non-sterile drugs or                 Dockets Management (see ADDRESSES). It
                                                  single copies of this guidance to the                   only repackaging biological products)                 is only necessary to send one set of
                                                  Division of Drug Information, Center for                should register as an outsourcing                     comments. Identify comments with the
                                                  Drug Evaluation and Research, Food                      facility. Because entities that register as           docket number found in brackets in the
                                                  and Drug Administration, 10001 New                      outsourcing facilities must pay a                     heading of this document. Received
                                                  Hampshire Ave., Hillandale Building,                    registration fee and FDA has determined               comments may be seen in the Division


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Document Created: 2016-09-27 22:27:22
Document Modified: 2016-09-27 22:27:22
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 October 13, 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 48322 

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