[Federal Register Volume 79, Number 214 (Wednesday, November 5, 2014)]
[Notices]
[Pages 65669-65670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1119]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Canning 
Establishment Registration, Process Filing, and Recordkeeping for 
Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically 
Sealed Containers; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a 
notice that appeared in the Federal Register of August 14, 2014. The 
notice announced that a proposed collection of information had been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance under the Paperwork Reduction Act of 1995. In this document, 
we correct some errors that appeared in the notice.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In FR Doc. 2014-19241, appearing on page 
47642 in the Federal Register of August 14, 2014 (79 FR 47642), we make 
the following corrections:
    1. On page 47643, in the second column, in the Response to Comment 
3, delete the sentence starting with ``The scope of the voluntary 
submission . . . and the product label.''
    2. On page 47643, in the second column, in the Response to Comment 
3, in the sentence starting with ``Consequently, we have proposed . . 
.,'' delete ``institute the voluntary consultation process discussed in 
this document'' and replace it with ``provide for the voluntary 
registration and Form FDA 2541e submission process''.
    3. On page 47643, in the second and third columns, in the Response 
to Comment 3, delete the sentences starting with ``The ability to 
submit a voluntary submission . . . of part 114'' and the remaining 
sentences in the response and replace them with ``FDA has authority to 
implement the voluntary submission process under sections 402 and 404 
of the FD&C Act.''
    4. On page 47643, in the third column, in the Response to Comment 
4, replace the response with the following: ``A voluntary process 
filing submission will not result in part 114 applying to products that 
are not acidified foods as defined in 21 CFR 114.3(b). Further, the 
voluntary process filing submission process will not result in any 
changes to part 114.''
    5. On pages 47643 to 47644, in the third column on page 47643 and 
in the first column on page 47644, in the Response to Comment 5, 
replace the response with the following: ``Our inspectors will not 
expect all manufacturers to submit voluntary submissions.''
    6. On page 47644, in the first column, in the Response to Comment 
7, replace the response with the following: ``As discussed in the 
response to Comment 4, if a product is not an acidified food, the 
product is not subject to the good manufacturing practice requirements 
in part 114 and will not become subject to those regulations as a 
result of a voluntary submission.''
    7. On page 47644, in the first and second columns, in the Response 
to Comment 8, replace the response with the following: ``The draft 
guidance did address the issue of what constitutes a fermented food. We 
expect that the acidified foods guidance, when finalized, will provide 
guidance on what constitutes a fermented food.''
    8. On page 47644, in the second column, in the Response to Comment 
9, replace the response with the following: ``Manufacturers are free to 
decide whether to make a voluntary submission, and we believe that some 
manufacturers may choose to do so. For FDA, the voluntary submission 
results in increased efficiency.''
    9. On page 47644, in the second and third columns, in the Response 
to Comment 10, delete the first paragraph of the response and delete 
the second sentence in the second paragraph of the response.
    10. On page 47645, in the first column, in the Response to Comment 
13, in the second sentence in the second paragraph of the response, 
delete ``to prevent the detention of product''.
    11. On page 47645, in the third column, in the Response to Comment 
20, in the first sentence of the response, replace ``and provides'' 
with ``and, when finalized, will provide''.

[[Page 65670]]

    12. On page 47646, in the first column, in the Response to Comment 
21, in the first sentence of the response, delete ``from the coverage 
of part 114'' and, at the end of the first sentence of the response, 
insert ``or that do not otherwise meet the definitions of acidified 
food.''
    13. On page 47646, in the first column, in the Response to Comment 
22, replace the response with the following: ``FDA does not agree that 
the `Food Product Group' categories in any way indicates FDA's thinking 
as to whether all fruit and vegetable juices are acidified foods and 
are therefore subject to the acidified foods regulations in parts 108 
and 114. Rather, the `Food Product Group' categories are designed to 
help FDA understand the nature of products. For more information on 
what constitutes an acidified food, we recommend manufacturers consult 
the definition of acidified foods in Sec.  114.3(b).''
    14. On page 47646, in the second column, in the Response to Comment 
24, replace the second paragraph of the response with the following: 
``When optional information about the `Food Product Group' category is 
provided, we will use it to help us understand the nature of the 
products and to help us prioritize which facilities to inspect.''

    Dated: October 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26238 Filed 11-4-14; 8:45 am]
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