Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 69689-69690 [2013-27811]

Download as PDF 69689 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1427] Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 information collection provisions of our regulations mandating the application of hazard analysis and critical control point (HAACP) principles to the processing of fruit and vegetable juices. DATES: Submit either electronic or written comments on the collection of information by January 21, 2014. 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, 1350 Piccard SUMMARY: Dr., PI50–400B, Rockville, MD 20850, 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. Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice—21 CFR Part 120 (OMB Control Number 0910–0466)—Extension FDA regulations in part 120 (21 CFR part 120) mandate the application of HACCP principles to the processing of fruit and vegetable juices. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA’s statutory authority to regulate food safety under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. The Agency also has authority under section 361 of the Public Health Service Act (42 U.S.C. 264) to issue and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases from one State, territory or possession to another, or from outside the United States into this country. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of that act. The rationale in establishing an HACCP system of preventive controls is to design and check the process so that the final product is not contaminated— not test for contamination after it may have taken place. Under HACCP, processors of fruit and vegetable juices establish and follow a preplanned sequence of operations and observations (the HACCP plan) designed to avoid or eliminate one or more specific food hazards, and thereby ensure that their products are safe, wholesome, and not adulterated, in compliance with section 402 of the FD&C Act. Information development and recordkeeping are essential parts of any HACCP system. The information collection requirements are narrowly tailored to focus on the development of appropriate controls and document those aspects of processing that are critical to food safety. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeeper tkelley on DSK3SPTVN1PROD with NOTICES 21 CFR Section 120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correction records for Sanitation Standard Operating Procedures. ..................................................... 120.7 and 120.12(a)(2), (b) and (c)—Require written hazard analysis of food hazards. ........................................... VerDate Mar<15>2010 16:04 Nov 19, 2013 Jkt 232001 PO 00000 Frm 00050 Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 1,875 365 684,375 0.1 68,438 2,300 1.1 2,530 20 50,600 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1 69690 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Notices TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeeper 21 CFR Section 120.8(b)(7) and 120.12(a)(4)(i) and (b)—Require a recordkeeping system that documents monitoring of the critical control points and other measurements as prescribed in the HACCP plan. .............................................................. 120.10(c) and 120.12(a)(4)(ii) and (b)—Require that all corrective actions taken in response to a deviation from a critical limit be documented. ......................................... 120.11(a)(1)(iv) and (a)(2), and 120.12 (a)(5)—Require records showing that process monitoring instruments are properly calibrated and that end-product or in-process testing is performed in accordance with written procedures. ............................................................................ 120.11(b) and 120.12(a)(5) and (b) - .................................. Require that every processor record the validation that the HACCP plan is adequate to control food hazards that are likely to occur. ............................................................ 120.14(a)(2), (c), and (d)—Require that importers of fruit or vegetable juices, or their products used as ingredients in beverages, have written procedures to ensure that the food is processed in accordance with our regulations in part 120. ............................................................ 120.11(c) and 120.12(a)(5) and (b)—Require documentation of revalidation of the hazard analysis upon any changes that might affect the original hazard analysis (applies when a firm does not have an HACCP plan because the original hazard analysis did not reveal hazards likely to occur.) ......................................................... Total .............................................................................. 1 There Average burden per recordkeeping Total annual records Total hours 1,450 14,600 21,170,000 0.01 211,700 1,840 12 22,080 0.1 2,208 1,840 52 95,680 0.1 9,568 1,840 1 1,840 4 7,360 308 1 308 4 1,232 1,840 1 1,840 4 7,360 ........................ ........................ ........................ ........................ 358,466 are no capital costs or operating and maintenance costs associated with this collection of information. Table 1 provides our estimate of the total annual recordkeeping burden of our regulations in part 120. We base our estimate of the average burden per recordkeeping on our experience with the application of HACCP principles in food processing. We base our estimate of the number of recordkeepers on our estimate of the total number of juice manufacturing plants affected by the regulations (plants identified in our official establishment inventory plus very small apple juice and very small orange juice manufacturers). These estimates assume that every processor will prepare sanitary standard operating procedures and an HACCP plan and maintain the associated monitoring records, and that every importer will require product safety specifications. In fact, there are likely to be some small number of juice processors that, based upon their hazard analysis, determine that they are not required to have an HACCP plan under these regulations. tkelley on DSK3SPTVN1PROD with NOTICES Number of records per recordkeeper Dated: November 15, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27811 Filed 11–19–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:04 Nov 19, 2013 Jkt 232001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–0576] Draft Guidance for Industry: Considerations for the Design of EarlyPhase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ‘‘Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products’’ that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products. In the notice, we SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 requested comments on the draft guidance. We are taking this action to allow interested persons additional time to submit comments and to allow for public discussion at the February 25–26, 2014, Cellular, Tissue, and Gene Therapies Advisory Committee meeting, where FDA will present the draft guidance document for review. DATES: FDA is extending the comment period on the draft guidance. Submit either electronic or written comments by May 9, 2014. ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your request. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69689-69690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27811]



[[Page 69689]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1427]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Hazard Analysis and Critical Control Point Procedures 
for the Safe and Sanitary Processing and Importing of Juice

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 information collection 
provisions of our regulations mandating the application of hazard 
analysis and critical control point (HAACP) principles to the 
processing of fruit and vegetable juices.

DATES: Submit either electronic or written comments on the collection 
of information by January 21, 2014.

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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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.

Hazard Analysis and Critical Control Point (HACCP) Procedures for the 
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120 
(OMB Control Number 0910-0466)--Extension

    FDA regulations in part 120 (21 CFR part 120) mandate the 
application of HACCP principles to the processing of fruit and 
vegetable juices. HACCP is a preventive system of hazard control 
designed to help ensure the safety of foods. The regulations were 
issued under FDA's statutory authority to regulate food safety under 
section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a 
food is adulterated if it is prepared, packed, or held under insanitary 
conditions whereby it may have been contaminated with filth or rendered 
injurious to health. The Agency also has authority under section 361 of 
the Public Health Service Act (42 U.S.C. 264) to issue and enforce 
regulations to prevent the introduction, transmission, or spread of 
communicable diseases from one State, territory or possession to 
another, or from outside the United States into this country. Under 
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to 
issue regulations for the efficient enforcement of that act.
    The rationale in establishing an HACCP system of preventive 
controls is to design and check the process so that the final product 
is not contaminated--not test for contamination after it may have taken 
place. Under HACCP, processors of fruit and vegetable juices establish 
and follow a preplanned sequence of operations and observations (the 
HACCP plan) designed to avoid or eliminate one or more specific food 
hazards, and thereby ensure that their products are safe, wholesome, 
and not adulterated, in compliance with section 402 of the FD&C Act. 
Information development and recordkeeping are essential parts of any 
HACCP system. The information collection requirements are narrowly 
tailored to focus on the development of appropriate controls and 
document those aspects of processing that are critical to food safety.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of      records per    Total annual     burden per      Total hours
                                   recordkeeper    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and              1,875             365         684,375             0.1          68,438
 (b)--Require written monitoring
 and correction records for
 Sanitation Standard Operating
 Procedures.....................
120.7 and 120.12(a)(2), (b) and            2,300             1.1           2,530              20          50,600
 (c)--Require written hazard
 analysis of food hazards.......

[[Page 69690]]

 
120.8(b)(7) and 120.12(a)(4)(i)            1,450          14,600      21,170,000            0.01         211,700
 and (b)--Require a
 recordkeeping system that
 documents monitoring of the
 critical control points and
 other measurements as
 prescribed in the HACCP plan...
120.10(c) and 120.12(a)(4)(ii)             1,840              12          22,080             0.1           2,208
 and (b)--Require that all
 corrective actions taken in
 response to a deviation from a
 critical limit be documented...
120.11(a)(1)(iv) and (a)(2), and           1,840              52          95,680             0.1           9,568
 120.12 (a)(5)--Require records
 showing that process monitoring
 instruments are properly
 calibrated and that end-product
 or in-process testing is
 performed in accordance with
 written procedures.............
120.11(b) and 120.12(a)(5) and             1,840               1           1,840               4           7,360
 (b) -..........................
Require that every processor
 record the validation that the
 HACCP plan is adequate to
 control food hazards that are
 likely to occur................
120.14(a)(2), (c), and (d)--                 308               1             308               4           1,232
 Require that importers of fruit
 or vegetable juices, or their
 products used as ingredients in
 beverages, have written
 procedures to ensure that the
 food is processed in accordance
 with our regulations in part
 120............................
120.11(c) and 120.12(a)(5) and             1,840               1           1,840               4           7,360
 (b)--Require documentation of
 revalidation of the hazard
 analysis upon any changes that
 might affect the original
 hazard analysis (applies when a
 firm does not have an HACCP
 plan because the original
 hazard analysis did not reveal
 hazards likely to occur.)......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         358,466
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 provides our estimate of the total annual recordkeeping 
burden of our regulations in part 120. We base our estimate of the 
average burden per recordkeeping on our experience with the application 
of HACCP principles in food processing. We base our estimate of the 
number of recordkeepers on our estimate of the total number of juice 
manufacturing plants affected by the regulations (plants identified in 
our official establishment inventory plus very small apple juice and 
very small orange juice manufacturers). These estimates assume that 
every processor will prepare sanitary standard operating procedures and 
an HACCP plan and maintain the associated monitoring records, and that 
every importer will require product safety specifications. In fact, 
there are likely to be some small number of juice processors that, 
based upon their hazard analysis, determine that they are not required 
to have an HACCP plan under these regulations.

    Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27811 Filed 11-19-13; 8:45 am]
BILLING CODE 4160-01-P