Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions, 52124-52125 [E6-14510]

Download as PDF 52124 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0328] Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions AGENCY: Food and Drug Administration, HHS. sroberts on PROD1PC70 with NOTICES 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 food additive petitions regarding animal feed. DATES: Submit written or electronic comments on the collection of information by October 31, 2006. ADDRESSES: Submit electronic comments on the collection of information to: https://www.fda.gov/ dockets/ecomments. 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: Denver Presley, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1472. 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, VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 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. Food Additive Petitions—21 CFR Part 571 (OMB Control Number 0910– 0546)—Extension Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the act (21 U.S.C. 348(b)) specifies the information that must be submitted by a petition in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use. To implement the provision of section 409 of the act (21 U.S.C. 348), procedural regulations have been issued under part 571 (21 CFR part 571). These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the law. The regulations add no substantive requirements to those indicated in the law, but attempt to explain the requirements and provide a standard format for submission to speed the processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in 21 CFR parts 573 and 582. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions. PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 On September 29, 2004, OMB approved a new information collection on food additive petitions submitted by the Center for Veterinary Medicine (CVM), FDA. The terms of clearance for this information collection stated that, given the interrelatedness of this collection to the information collected under OMB control number 0910–0016 by the Center for Food Safety and Applied Nutrition (CFSAN), FDA should consider merging the two collections. In consultation with CFSAN, CVM has decided not to merge these two collections, because what was once a food additive petitions approval (0910–0016), is now also the approval for affirmation of generally recognized as safe (GRAS) status (formerly OMB control number 0910–0132), labeling requirements for color additives (other than hair dyes) and petitions (formerly OMB control number 0910–0185), electronic submission of food and color additive petitions (formerly OMB control number 0910–0480), and substances approved for use in the preparation of meat and poultry products (formerly OMB control number 0910–0461). Thus, adding one CVM process to a collection now containing four dissimilar CFSAN processes is not justifiable anymore. Finally, the CVM food additive petition process stems from a different section of the CFR and the two processes are handled separately. CVM’s food additive petition process relates to part 571; CFSAN’s process relates to 21 CFR part 171. There is no efficiency in discussing these separate processes in a single collection of information. Respondents are expected to be the veterinary feed industry. FDA estimates the burden of this collection of information as follows: The estimated annual burden for this information collection is 18,000 hours. Food additive petitions submitted to CVM are estimated to fall into one of two categories of complexity that also can be used to represent estimates of the information collection burden for food additive petitions. These include only expected petitions for food additives not eligible for exemption under new section 409(h) of the act (21 U.S.C. 348(h)). Under § 571.1(c) moderate category, for food additive petitions without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. An average of one petitions of this type is received on an annual basis, resulting in a burden of 3,000 hours. Under § 571.1(c) complex category, for a food additive petition with E:\FR\FM\01SEN1.SGM 01SEN1 Federal Register / Vol. 71, No. 170 / Friday, September 1, 2006 / Notices complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 10,000 hours. Under § 571.6, for a food additive petition amendment, the estimated time requirement per petition is 52125 approximately 1,300 hours. An average of four petitions of this type are received on an annual basis, resulting in a burden of 5,200 hours. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency of Response Total Annual Responses Hours per Response Total Hours 571.1(c) moderate category 1 1 1 3,000 3,000 571.1(c) complex category 1 1 1 10,000 10,000 571.6 2 2 4 1,300 5,200 Total 18,200 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 28, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–14510 Filed 8–31–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Annual Guidance Agenda [Docket No. 2004N–0234] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA’s good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones. DATES: Submit written or electronic comments on this list and on any agency guidance documents at any time. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: For general information regarding FDA’s GGP policy: Lisa Helmanis, Office of Policy (HF–26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301– 827–3480. For information regarding specific topics or guidances: Please see contact persons listed in the table in the SUPPLEMENTARY INFORMATION section. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of September 19, 2000 (65 FR 56468), FDA’s issued its final rule on GGPs (21 CFR 10.115). GGPs are intended to ensure involvement of the public in the development of guidance documents and to enhance understanding of the availability, nature, and legal effect of such guidance documents. As part of FDA’s effort to ensure meaningful interaction with the public regarding guidance documents, the agency committed to publishing an annual guidance document agenda of possible guidance topics or documents for development or revision during the coming year. The agency also committed to soliciting public input regarding these and additional ideas for new topics or revisions to existing guidance documents (65 FR 56477; 21 CFR 10.115(f)(5)). The agency is neither bound by this list of possible topics nor required to issue every guidance document on this list or precluded from issuing guidance documents not on the list set forth in this document. The following list of guidance topics or documents represents possible new topics or revisions to existing guidance documents that the agency is considering. The agency solicits comments on the topics listed in this document and also seeks additional ideas from the public. The guidance documents are organized by the issuing Center or Office within FDA, and, in some cases, are further grouped by topic categories. The agency’s contact persons for each specific area are listed in the tables that follow. II. Center for Biologics Evaluation and Research (CBER) TITLE/TOPIC OF GUIDANCE CONTACT sroberts on PROD1PC70 with NOTICES CATEGORY—COMPLIANCE AND INSPECTION Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–6210. Design, Operation, and Validation of Heating, Ventilation, and Air Conditioning (HVAC) Systems Used in the Manufacture of Products Regulated by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research Same as above (Do) CATEGORY—BLOOD AND BLOOD COMPONENTS Reentry Algorithm for Donors Who Are Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc) VerDate Aug<31>2005 16:21 Aug 31, 2006 Jkt 208001 PO 00000 Frm 00074 Fmt 4703 Do Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1

Agencies

[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Notices]
[Pages 52124-52125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14510]



[[Page 52124]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0328]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Additive Petitions

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 food additive petitions 
regarding animal feed.

DATES: Submit written or electronic comments on the collection of 
information by October 31, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: https://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

Food Additive Petitions--21 CFR Part 571 (OMB Control Number 0910-
0546)--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(a)), provides that a food additive shall be deemed 
to be unsafe unless its use is permitted by a regulation which 
prescribes the condition(s) under which it may safely be used, or 
unless it is exempted by regulation for investigational use. Section 
409(b) of the act (21 U.S.C. 348(b)) specifies the information that 
must be submitted by a petition in order to establish the safety of a 
food additive and to secure the issuance of a regulation permitting its 
use.
    To implement the provision of section 409 of the act (21 U.S.C. 
348), procedural regulations have been issued under part 571 (21 CFR 
part 571). These procedural regulations are designed to specify more 
thoroughly the information that must be submitted to meet the 
requirement set down in broader terms by the law. The regulations add 
no substantive requirements to those indicated in the law, but attempt 
to explain the requirements and provide a standard format for 
submission to speed the processing of the petition. Labeling 
requirements for food additives intended for animal consumption are 
also set forth in various regulations contained in 21 CFR parts 573 and 
582. The labeling regulations are considered by FDA to be cross-
referenced to Sec.  571.1, which is the subject of this same OMB 
clearance for food additive petitions.
    On September 29, 2004, OMB approved a new information collection on 
food additive petitions submitted by the Center for Veterinary Medicine 
(CVM), FDA. The terms of clearance for this information collection 
stated that, given the interrelatedness of this collection to the 
information collected under OMB control number 0910-0016 by the Center 
for Food Safety and Applied Nutrition (CFSAN), FDA should consider 
merging the two collections. In consultation with CFSAN, CVM has 
decided not to merge these two collections, because what was once a 
food additive petitions approval (0910-0016), is now also the approval 
for affirmation of generally recognized as safe (GRAS) status (formerly 
OMB control number 0910-0132), labeling requirements for color 
additives (other than hair dyes) and petitions (formerly OMB control 
number 0910-0185), electronic submission of food and color additive 
petitions (formerly OMB control number 0910-0480), and substances 
approved for use in the preparation of meat and poultry products 
(formerly OMB control number 0910-0461). Thus, adding one CVM process 
to a collection now containing four dissimilar CFSAN processes is not 
justifiable anymore. Finally, the CVM food additive petition process 
stems from a different section of the CFR and the two processes are 
handled separately. CVM's food additive petition process relates to 
part 571; CFSAN's process relates to 21 CFR part 171. There is no 
efficiency in discussing these separate processes in a single 
collection of information.
    Respondents are expected to be the veterinary feed industry.
    FDA estimates the burden of this collection of information as 
follows:
    The estimated annual burden for this information collection is 
18,000 hours.
    Food additive petitions submitted to CVM are estimated to fall into 
one of two categories of complexity that also can be used to represent 
estimates of the information collection burden for food additive 
petitions. These include only expected petitions for food additives not 
eligible for exemption under new section 409(h) of the act (21 U.S.C. 
348(h)).
    Under Sec.  571.1(c) moderate category, for food additive petitions 
without complex chemistry, manufacturing, efficacy, or safety issues, 
the estimated time requirement per petition is approximately 3,000 
hours. An average of one petitions of this type is received on an 
annual basis, resulting in a burden of 3,000 hours.
    Under Sec.  571.1(c) complex category, for a food additive petition 
with

[[Page 52125]]

complex chemistry, manufacturing, efficacy, and/or safety issues, the 
estimated time requirement per petition is approximately 10,000 hours. 
An average of one petition of this type is received on an annual basis, 
resulting in a burden of 10,000 hours.
    Under Sec.  571.6, for a food additive petition amendment, the 
estimated time requirement per petition is approximately 1,300 hours. 
An average of four petitions of this type are received on an annual 
basis, resulting in a burden of 5,200 hours.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency  of     Total Annual        Hours per
                    21 CFR Section                         Respondents           Response            Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) moderate category                                              1                     1                  1              3,000              3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.1(c) complex category                                               1                     1                  1             10,000             10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
571.6                                                                   2                     2                  4              1,300              5,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             18,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14510 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S
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