Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 28484-28486 [E8-10985]

Download as PDF 28484 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices Dated: May 8, 2008. Joseph Henderson, Acting Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. E8–10986 Filed 5–15–08; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–267] Agency Information Collection Activities: Submission for OMB Review; Comment Request Centers for Medicare & Medicaid Services, Department of Health and Human Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency’s function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage Program: Application and Contract Requirements; Use: The information collection requirements are mandated by 42 CFR 422. Section 4001 of the Balanced Budget Act of 1997 added sections 1851 through 1859 to the Social Security Act to establish this new program. The Medicare, Medicaid, and SCHIP Benefits Improvement Act and Protection Act of 2000 and sections 201–204 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) added new requirements. Medicare Advantage (MA) organizations (formerly M+C organizations) and potential MA organizations (applicants) use the information to comply with the application requirements and the MA sroberts on PROD1PC70 with NOTICES AGENCY: VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 contract requirements. CMS will use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to MA organizations, determine compliance with the new prescription drug benefit requirements established by the MMA, and to ensure that correct information is disclosed to Medicare beneficiaries, both potential enrollees and enrollees. The reported change in burden is due to program growth and revisions to the Medicare Advantage and Prescription Drug Benefit. Form Number: CMS–R–267 (OMB# 0938–0753); Frequency: Yearly; Affected Public: Business or other forprofit and Not-for-profit institutions, and Individuals or households; Number of Respondents: 9,000,670; Total Annual Responses: 9,000,670; Total Annual Hours: 8,529,541. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on June 16, 2008. OMB Human Resources and Housing Branch, Attention: Carolyn Raffaelli, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395–6974. Dated: May 7, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–10664 Filed 5–15–08; 8:45 am] BILLING CODE 4120–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0094] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 16, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0562. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations—(OMB Control Number 0910–0562)—Extension The Food Quality Protection Act of 1996 (FQPA), which amended the Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1 28485 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (the act), established a new safety standard for pesticide residues in food, with an emphasis on protecting the health of infants and children. The Environmental Protection Agency (EPA) is responsible for regulating the use of pesticides (under FIFRA) and for establishing tolerances or exemptions from the requirement for tolerances for residues of pesticide chemicals in food commodities (under the act). EPA, in accordance with the FQPA, is in the process of reassessing the pesticide tolerances and exemptions which were in effect when the FQPA was signed into law. When EPA determines that a pesticide’s tolerance level does not meet the safety standard under section 408 of the act (21 U.S.C. 346a), the registration for the pesticide may be canceled under FIFRA for all or certain uses. In addition, the tolerances for that pesticide may be lowered or revoked for the corresponding food commodities. Under section 408(l)(2) of the act, when the registration for a pesticide is canceled or modified due to, in whole or in part, dietary risks to humans posed by residues of that pesticide chemical on food, the effective date for the revocation of such tolerance (or exemption in some cases) must be no later than 180 days after the date such cancellation becomes effective or 180 days after the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later. When EPA takes such actions, food derived from a commodity that was lawfully treated with the pesticide may not have cleared the channels of trade by the time the revocation or new tolerance level takes effect. The food could be found by FDA, the agency that is responsible for monitoring pesticide residue levels and enforcing the pesticide tolerances in most foods (the U.S. Department of Agriculture (USDA) has responsibility for monitoring residue levels and enforcing pesticide tolerances in egg products and most meat and poultry products), to contain a residue of that pesticide that does not comply with the revoked or lowered tolerance. FDA would normally deem such food to be in violation of the law by virtue of it bearing an illegal pesticide residue. The food would be subject to FDA enforcement action as an ‘‘adulterated’’ food. However, the channels of trade provision of the act (section 408(l)(5) of the act) addresses the circumstances under which a food is not unsafe solely due to the presence of a residue from a pesticide chemical for which the tolerance has been revoked, suspended, or modified by EPA. The channels of trade provision states that food containing a residue of such a pesticide shall not be deemed ‘‘adulterated’’ by virtue of the residue, if the residue is within the former tolerance, and the responsible party can demonstrate to FDA’s satisfaction that the residue is present as the result of an application of the pesticide at a time and in a manner which were lawful under FIFRA. In the Federal Register of May 18, 2005 (70 FR 28544), FDA announced the availability of a guidance document entitled, ‘‘Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.’’ The guidance represents the agency’s current thinking on its planned enforcement approach to the channels of trade provision of the act and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA under dietary risk considerations. The guidance can be found at http:// www.cfsan.fda.gov/guidance.html. FDA anticipates that food bearing lawfully applied residues of pesticide chemicals that are the subject of future EPA action to revoke, suspend, or modify their tolerances, will remain in the channels of trade after the applicable tolerance is revoked, suspended, or modified. If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance. In general, FDA anticipates that the party responsible for food found to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the guidance by providing appropriate documentation to the agency as discussed in the guidance document. FDA is not suggesting that firms maintain an inflexible set of documents where anything less or different would likely be considered unacceptable. Rather, the agency is leaving it to each firm’s discretion to maintain appropriate documentation to demonstrate that the food was so handled during the acceptable timeframes. Examples of documentation which FDA anticipates will serve this purpose consist of documentation associated with packing codes, batch records, and inventory records. These are types of documents that many food processors routinely generate as part of their basic food-production operations. FDA is requesting the extension of OMB approval for the information collection provisions in the guidance. Description of Respondents: The likely respondents to this collection of information are firms in the produce and food-processing industries that handle food products that may contain residues of pesticide chemicals after the tolerances for the pesticide chemicals have been revoked, suspended, or modified. In the Federal Register of February 25, 2008 (73 FR 10033), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Activity No. of Respondents Submission of documentation sroberts on PROD1PC70 with NOTICES 1There Annual Frequency per Response 1 Total Annual Responses 1 Hours per Response 1 Total Hours 3 3 are no capital costs or operating and maintenance costs associated with this collection of information. FDA expects the total number of pesticide tolerances that are revoked, suspended, or modified by EPA in the next 3 years to significantly decrease, as VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 EPA concludes its review activity. Thus, the previous estimates for respondents and numbers of responses in table 1 of this document are based on the PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 submissions that the agency has received in the past 3 years and the expectation that the number of submissions will significantly decrease E:\FR\FM\16MYN1.SGM 16MYN1 28486 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices in the next 3 years. However, to avoid counting this burden as zero, FDA has estimated the burden at one respondent making one submission a year for a total of one annual submission. The hours per response values were estimated as follows: First, we assumed that the information requested in the guidance is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter’s company and to prepare this information for submission to FDA. The submitter will almost always merely need to copy existing documentation. We believe that this effort should take no longer than 3 hours per submission. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Activity Develop documentation process 1There Annual Frequency per Recordkeeping 1 Total Annual Records 1 1 Total Hours 16 16 are no capital costs or operating and maintenance costs associated with this collection of information. In determining the estimated annual recordkeeping burden, FDA estimated that at least 90 percent of firms maintain documentation, such as packing codes, batch records, and inventory records, as part of their basic food production or import operations. Therefore, the recordkeeping burden was calculated as the time required for the 10 percent of firms that may not be currently maintaining this documentation to develop and maintain documentation, such as batch records and inventory records. In previous information collection requests, this recordkeeping burden was estimated to be 16 hours per record. FDA has retrained its prior estimate of 16 hours per record for the recordkeeping burden. As shown in table 1 of this document, FDA estimates that one respondent will make one submission per year. Although FDA estimates that only 1 out of 10 firms will not be currently maintaining the necessary documentation, to avoid counting the recordkeeping burden for the 1 submission per year as 1/10 of a recordkeeper, FDA estimates that 1 recordkeeper will take 16 hours to develop and maintain documentation recommended by the guidance. Dated: May 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–10985 Filed 5–15–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES collection of information to OMB for review and clearance. Food and Drug Administration Adverse Experience Reporting for Licensed Biological Products; and General Records—(OMB Control Number 0910–0308)—Extension Under the Public Health Service Act (42 U.S.C. 262), FDA is required to ensure the marketing of only those biological products which are safe and effective. FDA must, therefore, be informed of all adverse experiences occasioned by the use of licensed biological products. FDA issued the adverse experience reporting (AER) requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA’s AER system is to flag potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a biological product’s comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, physicians, foreign regulatory agencies, and clinical investigators. Information derived from the AER system contributes directly to increased public health protection because such information enables FDA to recommend important changes to the product’s labeling (such as adding a new warning), to initiate removal of a biological product from the market when necessary, and to assure the manufacturer has taken adequate corrective action if necessary. The regulation in § 600.80(c)(1) requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether [Docket No. FDA–2008–N–0073] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 16, 2008. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0308. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: sroberts on PROD1PC70 with NOTICES Hours per Record Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 73, Number 96 (Friday, May 16, 2008)]
[Notices]
[Pages 28484-28486]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10985]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0094]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Channels of Trade 
Policy for Commodities With Residues of Pesticide Chemicals, for Which 
Tolerances Have Been Revoked, Suspended, or Modified by the 
Environmental Protection Agency Pursuant to Dietary Risk Considerations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
16, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0562. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Channels of Trade Policy for Commodities With Residues of Pesticide 
Chemicals, for Which Tolerances Have Been Revoked, Suspended, or 
Modified by the Environmental Protection Agency Pursuant to Dietary 
Risk Considerations--(OMB Control Number 0910-0562)--Extension

    The Food Quality Protection Act of 1996 (FQPA), which amended the

[[Page 28485]]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
Federal Food, Drug, and Cosmetic Act (the act), established a new 
safety standard for pesticide residues in food, with an emphasis on 
protecting the health of infants and children. The Environmental 
Protection Agency (EPA) is responsible for regulating the use of 
pesticides (under FIFRA) and for establishing tolerances or exemptions 
from the requirement for tolerances for residues of pesticide chemicals 
in food commodities (under the act). EPA, in accordance with the FQPA, 
is in the process of reassessing the pesticide tolerances and 
exemptions which were in effect when the FQPA was signed into law. When 
EPA determines that a pesticide's tolerance level does not meet the 
safety standard under section 408 of the act (21 U.S.C. 346a), the 
registration for the pesticide may be canceled under FIFRA for all or 
certain uses. In addition, the tolerances for that pesticide may be 
lowered or revoked for the corresponding food commodities. Under 
section 408(l)(2) of the act, when the registration for a pesticide is 
canceled or modified due to, in whole or in part, dietary risks to 
humans posed by residues of that pesticide chemical on food, the 
effective date for the revocation of such tolerance (or exemption in 
some cases) must be no later than 180 days after the date such 
cancellation becomes effective or 180 days after the date on which the 
use of the canceled pesticide becomes unlawful under the terms of the 
cancellation, whichever is later.
    When EPA takes such actions, food derived from a commodity that was 
lawfully treated with the pesticide may not have cleared the channels 
of trade by the time the revocation or new tolerance level takes 
effect. The food could be found by FDA, the agency that is responsible 
for monitoring pesticide residue levels and enforcing the pesticide 
tolerances in most foods (the U.S. Department of Agriculture (USDA) has 
responsibility for monitoring residue levels and enforcing pesticide 
tolerances in egg products and most meat and poultry products), to 
contain a residue of that pesticide that does not comply with the 
revoked or lowered tolerance. FDA would normally deem such food to be 
in violation of the law by virtue of it bearing an illegal pesticide 
residue. The food would be subject to FDA enforcement action as an 
``adulterated'' food. However, the channels of trade provision of the 
act (section 408(l)(5) of the act) addresses the circumstances under 
which a food is not unsafe solely due to the presence of a residue from 
a pesticide chemical for which the tolerance has been revoked, 
suspended, or modified by EPA. The channels of trade provision states 
that food containing a residue of such a pesticide shall not be deemed 
``adulterated'' by virtue of the residue, if the residue is within the 
former tolerance, and the responsible party can demonstrate to FDA's 
satisfaction that the residue is present as the result of an 
application of the pesticide at a time and in a manner which were 
lawful under FIFRA.
    In the Federal Register of May 18, 2005 (70 FR 28544), FDA 
announced the availability of a guidance document entitled, ``Channels 
of Trade Policy for Commodities With Residues of Pesticide Chemicals, 
for Which Tolerances Have Been Revoked, Suspended, or Modified by the 
Environmental Protection Agency Pursuant to Dietary Risk 
Considerations.'' The guidance represents the agency's current thinking 
on its planned enforcement approach to the channels of trade provision 
of the act and how that provision relates to FDA-regulated products 
with residues of pesticide chemicals for which tolerances have been 
revoked, suspended, or modified by EPA under dietary risk 
considerations. The guidance can be found at http://www.cfsan.fda.gov/
guidance.html. FDA anticipates that food bearing lawfully applied 
residues of pesticide chemicals that are the subject of future EPA 
action to revoke, suspend, or modify their tolerances, will remain in 
the channels of trade after the applicable tolerance is revoked, 
suspended, or modified. If FDA encounters food bearing a residue of a 
pesticide chemical for which the tolerance has been revoked, suspended, 
or modified, it intends to address the situation in accordance with 
provisions of the guidance. In general, FDA anticipates that the party 
responsible for food found to contain pesticide chemical residues 
(within the former tolerance) after the tolerance for the pesticide 
chemical has been revoked, suspended, or modified will be able to 
demonstrate that such food was handled, e.g., packed or processed, 
during the acceptable timeframes cited in the guidance by providing 
appropriate documentation to the agency as discussed in the guidance 
document. FDA is not suggesting that firms maintain an inflexible set 
of documents where anything less or different would likely be 
considered unacceptable. Rather, the agency is leaving it to each 
firm's discretion to maintain appropriate documentation to demonstrate 
that the food was so handled during the acceptable timeframes.
    Examples of documentation which FDA anticipates will serve this 
purpose consist of documentation associated with packing codes, batch 
records, and inventory records. These are types of documents that many 
food processors routinely generate as part of their basic food-
production operations.
    FDA is requesting the extension of OMB approval for the information 
collection provisions in the guidance.
    Description of Respondents: The likely respondents to this 
collection of information are firms in the produce and food-processing 
industries that handle food products that may contain residues of 
pesticide chemicals after the tolerances for the pesticide chemicals 
have been revoked, suspended, or modified.
    In the Federal Register of February 25, 2008 (73 FR 10033), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Activity                            Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of documentation                                             1                     1                  1                  3                  3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA expects the total number of pesticide tolerances that are 
revoked, suspended, or modified by EPA in the next 3 years to 
significantly decrease, as EPA concludes its review activity. Thus, the 
previous estimates for respondents and numbers of responses in table 1 
of this document are based on the submissions that the agency has 
received in the past 3 years and the expectation that the number of 
submissions will significantly decrease

[[Page 28486]]

in the next 3 years. However, to avoid counting this burden as zero, 
FDA has estimated the burden at one respondent making one submission a 
year for a total of one annual submission.
    The hours per response values were estimated as follows: First, we 
assumed that the information requested in the guidance is readily 
available to the submitter. We expect that the submitter will need to 
gather information from appropriate persons in the submitter's company 
and to prepare this information for submission to FDA. The submitter 
will almost always merely need to copy existing documentation. We 
believe that this effort should take no longer than 3 hours per 
submission.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                       Activity                           Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop documentation process                                           1                     1                  1                 16                 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In determining the estimated annual recordkeeping burden, FDA 
estimated that at least 90 percent of firms maintain documentation, 
such as packing codes, batch records, and inventory records, as part of 
their basic food production or import operations. Therefore, the 
recordkeeping burden was calculated as the time required for the 10 
percent of firms that may not be currently maintaining this 
documentation to develop and maintain documentation, such as batch 
records and inventory records. In previous information collection 
requests, this recordkeeping burden was estimated to be 16 hours per 
record. FDA has retrained its prior estimate of 16 hours per record for 
the recordkeeping burden. As shown in table 1 of this document, FDA 
estimates that one respondent will make one submission per year. 
Although FDA estimates that only 1 out of 10 firms will not be 
currently maintaining the necessary documentation, to avoid counting 
the recordkeeping burden for the 1 submission per year as 1/10 of a 
recordkeeper, FDA estimates that 1 recordkeeper will take 16 hours to 
develop and maintain documentation recommended by the guidance.

    Dated: May 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10985 Filed 5-15-08; 8:45 am]
BILLING CODE 4160-01-S