Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements, 18030-18031 [05-7023]

Download as PDF 18030 Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: State Petitions for Exemption From Preemption—21 CFR 100.1(d) (OMB Control Number 0910–0277)—Extension Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343–1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard-of-identity requirements. Section 100.1(d) (21 CFR 100.1(d)) sets forth the information a State is required to submit in such a petition. The information required under § 100.1(d) enables FDA to determine whether the State food labeling or standard-ofidentity requirement satisfies the criteria of section 403A(b) of the act for granting exemption from Federal preemption. In the Federal Register of January 13, 2005 (70 FR 2412), FDA published a 60day notice requesting public comment on the information collection provisions. One comment was received. The comment expresses concern that it is unnecessary for FDA to maintain a ‘‘program’’ whereby States may petition the FDA to request exemption from preemption because States are not asking for exemptions. The comment asserts that the ‘‘program’’ wastes taxpayer dollars and suggests that FDA abolish it. Under section 403A(b) of the act, States may petition FDA for exemption from Federal preemption of State food labeling and standard-of-identity requirements. FDA’s regulations at § 100.1(d), the subject matter of this information collection, set forth the information a State is required to submit in such a petition. Section 100.1(d) implements a statutory information collection requirement. Therefore, FDA cannot abolish the regulations unless the statute is changed. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Annual Frequency per Response 1 21 CFR Section 1 100.1(d) 1There Total Annual Responses Hours per Response Total Hours 40 40 1 are no capital costs or operating and maintenance costs associated with this collection of information. The reporting burden for § 100.1(d) is insignificant because petitions for exemption from preemption are seldom submitted by States. In the last 3 years, FDA has not received any new petitions; therefore, the agency estimates that one or fewer petitions will be submitted annually. Because § 100.1(d) implements a statutory information collection requirement, only the additional burden attributable to the regulation has been included in the estimate. Although FDA believes that the burden will be insignificant, the agency believes these information collection provisions should be extended to provide for the potential future need of a State or local government to petition for an exemption from preemption under the provisions of section 403(A) of the act. Dated: April 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–7022 Filed 4–7–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0541] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements 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 May 9, 2005. OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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, ADDRESSES: VerDate jul<14>2003 19:00 Apr 07, 2005 Jkt 205001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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. Exports: Notification and Recordkeeping Requirements—21 CFR Part 1 (OMB Control Number 0910– 0482)—Extension In the Federal Register of December 27, 2004 (69 FR 77255), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. The total burden estimate of 43,214 is based on the number of notifications received by the relevant FDA centers in fiscal year 2004, or the last year the figures were available. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or marketed in the United States as allowed under section 801(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381). In general, the notification identifies the product being exported (e.g., name, description, and, in some cases, country of destination) E:\FR\FM\08APN1.SGM 08APN1 18031 Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices and specifies where the notification should be sent. These notifications are sent only for an initial export; subsequent exports of the same product to the same destination, or in the case of certain countries identified in section 802(b) of the act (21 U.S.C. 382), would not result in a notification to FDA. The recordkeepers for this information collection are exporters who export human drugs, biologics, devices, animal drugs, foods, and cosmetics that may not be sold in the United States to maintain records demonstrating their compliance with the requirements in section 801(e)(1) of the act. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section 1.101(d) and (e) 1 There Annual Frequency per Response 419 Total Annual Responses 2.8 Hours per Respondent 1,164 Total Hours 17 19,788 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers 21 CFR Section 1.101(b) and (c) 1 There 324 2.8 Hours per Recordkeeper 901 scientific bodies of the U.S. Government. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0124] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body Food and Drug Administration, HHS. 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 a 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 collection of information associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of SUMMARY: VerDate jul<14>2003 19:00 Apr 07, 2005 Jkt 205001 Submit written or electronic comments on the collection of information by June 7, 2005. 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: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. 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 requirement 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 DATES: BILLING CODE 4160–01–S ACTION: Total Annual Records 26 Total Hours 23,426 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–7023 Filed 4–7–05; 8:45 am] AGENCY: Annual Frequency per Record PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 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. Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body (OMB Control Number 0910–0374)—Extension Section 403(r)(2)(G) and (r)(3)(C) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 343(r)(2)(G) and (r)(3)(C)), as amended by the FDA Modernization Act of 1997 (FDAMA), provides that a food producer may market a food product whose label bears a nutrient content claim or a health claim that is based on an authoritative statement of a scientific body of the U.S. Government or the National Academy of Sciences. Under this section of the act, a food producer that intends to use such E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18030-18031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7023]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0541]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Exports: Notification 
and Recordkeeping Requirements

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 May 9, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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.
    Exports: Notification and Recordkeeping Requirements--21 CFR Part 1 
(OMB Control Number 0910-0482)--Extension
    In the Federal Register of December 27, 2004 (69 FR 77255), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    The total burden estimate of 43,214 is based on the number of 
notifications received by the relevant FDA centers in fiscal year 2004, 
or the last year the figures were available.
    The respondents to this information collection are exporters who 
have notified FDA of their intent to export unapproved products that 
may not be sold or marketed in the United States as allowed under 
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 381). In general, the notification identifies the product 
being exported (e.g., name, description, and, in some cases, country of 
destination)

[[Page 18031]]

 and specifies where the notification should be sent. These 
notifications are sent only for an initial export; subsequent exports 
of the same product to the same destination, or in the case of certain 
countries identified in section 802(b) of the act (21 U.S.C. 382), 
would not result in a notification to FDA.
    The recordkeepers for this information collection are exporters who 
export human drugs, biologics, devices, animal drugs, foods, and 
cosmetics that may not be sold in the United States to maintain records 
demonstrating their compliance with the requirements in section 
801(e)(1) of the act.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses          Respondent        Total Hours
----------------------------------------------------------------------------------------------------------------
1.101(d) and (e)                 419                2.8              1,164                 17            19,788
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers        per Record          Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
1.101(b) and (c)                 324                2.8                901                 26            23,426
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7023 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S
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