Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations, 16018-16020 [E8-6060]

Download as PDF 16018 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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. Electronic Records; Electronic Signatures—21 CFR Part 11 (OMB Control Number 0910–0303)—Extension The FDA regulations in 21 CFR part 11 (part 11) provide criteria for acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records. Under these regulations, records and reports may be submitted to FDA electronically provided the agency has stated its ability to accept the records electronically in an agency-established public docket and that the other requirements of part 11 are met. The recordkeeping provisions in part 11 (§§ 11.10, 11.30, 11.50, and 11.300) require standard operating procedures to assure appropriate use of, and precautions for, systems using electronic records and signatures; (1) § 11.10 specifies procedures and controls for persons who use closed systems to create, modify, maintain, or transmit electronic records; (2) § 11.30 specifies procedures and controls for persons who use open systems to create, modify, maintain, or transmit electronic records; (3) § 11.50 specifies procedures and controls for persons who use electronic signatures; and (4) § 11.300 specifies controls to ensure the security and integrity of electronic signatures based upon use of identification codes in combination with passwords. The reporting provision (§ 11.100) requires persons to certify in writing to FDA that they will regard electronic signatures used in their systems as the legally binding equivalent of traditional handwritten signatures. The burden created by the information collection provision of this regulation is a one-time burden associated with the creation of standard operating procedures, validation, and certification. The agency anticipates the use of electronic media will substantially reduce the paperwork burden associated with maintaining FDA required records. The respondents will be businesses and other for-profit organizations, state or local governments, Federal agencies, and nonprofit institutions. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 11.100 1 There Annual Frequency per Response 4,500 Total Annual Responses 1 Hours per Response 4,500 Total Hours 1 4,500 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 11.10 2,500 1 2,500 20 50,000 11.30 2,500 1 2,500 20 50,000 11.50 4,500 1 4,500 20 90,000 11.300 4,500 1 4,500 20 90,000 Total pwalker on PROD1PC71 with NOTICES 1 There 280,000 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. Dated: March 19, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–6055 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0169] Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\26MRN1.SGM Notice. 26MRN1 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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 requirements related to the recall of infant formula. DATES: Submit written or electronic comments on the collection of information by May 27, 2008. 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: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 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 SUPPLEMENTARY INFORMATION: 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. Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280 (OMB Control Number 0910–0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant formula has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer has left its control and may not provide the nutrients required in section 412(i) of the act or is otherwise adulterated or misbranded, the manufacturer must promptly notify the Secretary of Health and Human Services (the Secretary). If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. Section 412(f)(2) of the act states that the Secretary shall by regulation prescribe the scope and extent of recalls of infant formula necessary and appropriate for the degree of risk to human health presented by the formula subject to recall. FDA’s infant formula recall regulations in part 107 (21 CFR 16019 part 107) implement these statutory provisions. Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements: (1) Evaluate the hazard to human health, (2) devise a written recall strategy, (3) promptly notify each affected direct account (customer) about the recall, and (4) furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements: (1) Notify the appropriate FDA district office of the recall by telephone within 24 hours, (2) submit a written report to that office within 14 days, and (3) submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence (§ 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications (§ 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula (§ 107.280). The reporting and recordkeeping requirements described previously are designed to enable FDA to monitor the effectiveness of infant formula recalls in order to protect babies from infant formula that may be unsafe because of contamination or nutritional inadequacy or otherwise adulterated or misbranded. FDA uses the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents pwalker on PROD1PC71 with NOTICES 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 107.230 2 1 2 4,500 9,000 107.240 2 1 2 1,482 2,964 VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\26MRN1.SGM 26MRN1 16020 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 107.250 2 1 2 120 240 107.260 1 1 1 650 650 Total 12,854 1There are no capital costs or operating and maintenance costs associated with this collection of information. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. The reporting burden estimate is based on agency records, which show that there are five manufacturers of infant formula and that there have been, on average, two infant formula recalls per year for the past 3 years. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only. Dated: March 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–6060 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration pwalker on PROD1PC71 with NOTICES Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 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. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2008–N–0170] AGENCY: 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 procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit to FDA information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe. DATES: Submit written or electronic comments on the collection of information by May 27, 2008. 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: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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. Premarket Notification for a New Dietary Ingredient—21 CFR 190.6 (OMB Control Number 0910–0330)— Extension Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains a new dietary ingredient, a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit to FDA (as delegate for the Secretary of Health and Human Services) information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe. Part 190 (21 CFR part 190) implements these statutory provisions. Section 190.6(a) requires each E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16018-16020]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0169]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Infant Formula Recall Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 16019]]

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 requirements related to the 
recall of infant formula.

DATES: Submit written or electronic comments on the collection of 
information by May 27, 2008.

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: 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: 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.

Infant Formula Recall Regulations--21 CFR 107.230, 107.240, 107.250, 
107.260, and 107.280 (OMB Control Number 0910-0188)--Extension

    Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant 
formula has knowledge that reasonably supports the conclusion that an 
infant formula processed by that manufacturer has left its control and 
may not provide the nutrients required in section 412(i) of the act or 
is otherwise adulterated or misbranded, the manufacturer must promptly 
notify the Secretary of Health and Human Services (the Secretary). If 
the Secretary determines that the infant formula presents a risk to 
human health, the manufacturer must immediately take all actions 
necessary to recall shipments of such infant formula from all wholesale 
and retail establishments, consistent with recall regulations and 
guidelines issued by the Secretary. Section 412(f)(2) of the act states 
that the Secretary shall by regulation prescribe the scope and extent 
of recalls of infant formula necessary and appropriate for the degree 
of risk to human health presented by the formula subject to recall. 
FDA's infant formula recall regulations in part 107 (21 CFR part 107) 
implement these statutory provisions.
    Section 107.230 requires each recalling firm to conduct an infant 
formula recall with the following elements: (1) Evaluate the hazard to 
human health, (2) devise a written recall strategy, (3) promptly notify 
each affected direct account (customer) about the recall, and (4) 
furnish the appropriate FDA district office with copies of these 
documents. If the recalled formula presents a risk to human health, the 
recalling firm must also request that each establishment that sells the 
recalled formula post (at point of purchase) a notice of the recall and 
provide FDA with a copy of the notice. Section 107.240 requires the 
recalling firm to conduct an infant formula recall with the following 
elements: (1) Notify the appropriate FDA district office of the recall 
by telephone within 24 hours, (2) submit a written report to that 
office within 14 days, and (3) submit a written status report at least 
every 14 days until the recall is terminated. Before terminating a 
recall, the recalling firm is required to submit a recommendation for 
termination of the recall to the appropriate FDA district office and 
wait for written FDA concurrence (Sec.  107.250). Where the recall 
strategy or implementation is determined to be deficient, FDA may 
require the firm to change the extent of the recall, carry out 
additional effectiveness checks, and issue additional notifications 
(Sec.  107.260). In addition, to facilitate location of the product 
being recalled, the recalling firm is required to maintain distribution 
records for at least 1 year after the expiration of the shelf life of 
the infant formula (Sec.  107.280).
    The reporting and recordkeeping requirements described previously 
are designed to enable FDA to monitor the effectiveness of infant 
formula recalls in order to protect babies from infant formula that may 
be unsafe because of contamination or nutritional inadequacy or 
otherwise adulterated or misbranded. FDA uses the information collected 
under these regulations to help ensure that such products are quickly 
and efficiently removed from the market.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
                      21 CFR Section                          Respondents        per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.230                                                                    2                  1                  2              4,500              9,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.240                                                                    2                  1                  2              1,482              2,964
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 16020]]

 
107.250                                                                    2                  1                  2                120                240
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.260                                                                    1                  1                  1                650                650
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                      .................  .................  .................  .................             12,854
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources 
necessary to comply with a collection of information are excluded from 
the burden estimate if the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary because they would 
occur in the normal course of activities. No burden has been estimated 
for the recordkeeping requirement in Sec.  107.280 because these 
records are maintained as a usual and customary part of normal business 
activities. Manufacturers keep infant formula distribution records for 
the prescribed period as a matter of routine business practice.
    The reporting burden estimate is based on agency records, which 
show that there are five manufacturers of infant formula and that there 
have been, on average, two infant formula recalls per year for the past 
3 years.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6060 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S