Agency Information Collection Activities; Submission for Office of Managment and Budget Review; Comment Request; State Petitions for Exemption From Preemption, 18029-18030 [05-7022]

Download as PDF 18029 Federal Register / Vol. 70, No. 67 / Friday, April 8, 2005 / Notices Charter are also available on the Internet at https://www.cms.hhs.gov/faca. Authority: Section 1833(t)(9)(A) of the Act (42 U.S.C. 13951(t)(9)(A). The Panel is governed by the provisions of Pub. L. 92–463, as amended (5 U.S.C. Appendix 2). (Catalog of Federal Domestic Assistance Program No. 93.774, MedicareSupplementary Medical Insurance Program) Dated: March 31, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 05–6862 Filed 4–7–05; 8:45 am] BILLING CODE 4120–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0564] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications 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 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: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. 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. Temporary Marketing Permit Applications—21 CFR 130.17(c) and (i) (OMB Control Number 0910–0133)— Extension Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 341), directs FDA to issue regulations establishing definitions and standards of identity for food ‘‘[w]henever * * * such action will promote honesty and fair dealing in the interest of consumers * * * ’’. Under section 403(g) of the act (21 U.S.C. 343(g)), a food that is subject to a definition and standard of identity prescribed by regulation is misbranded if it does not conform to such definition and standard of identity. Section 130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary marketing permits that enable the food industry to test consumer acceptance and measure the technological and commercial feasibility in interstate commerce of experimental packs of food that deviate from applicable definitions and standards of identity. Section 130.17(c) enables the agency to monitor the manufacture, labeling, and distribution of experimental packs of food that deviate from applicable definitions and standards of identity. The information so obtained can be used in support of a petition to establish or amend the applicable definition or standard of identity to provide for the variations. Section 130.17(i) specifies the information that a firm must submit to FDA to obtain an extension of a temporary marketing permit. In the Federal Register of January 13, 2005 (70 FR 2411), FDA published a 60day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of the collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Number of Respondents 21 CFR section Annual Frequency per Response Total Annual Responses Hours per Response Total hours 130.17(c) 3 2 6 25 150 130.17(i) 4 2 8 2 16 Total 1There 166 are no capital costs or operating and maintenance costs associated with this collection of information. The estimated number of temporary marketing permit applications and hours per response is an average based on the agency’s experience with applications received October 1, 2001, through September 30, 2004, and information from firms that have submitted recent requests for temporary marketing permits. Dated: April 1, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–7021 Filed 4–7–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N–0565] Food and Drug Administration, HHS. ACTION: BILLING CODE 4160–01–S Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing VerDate jul<14>2003 19:00 Apr 07, 2005 Jkt 205001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 Fax written comments on the collection of information by May 9, 2005. DATES: Agency Information Collection Activities; Submission for Office of Managment and Budget Review; Comment Request; State Petitions for Exemption From Preemption AGENCY: 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. 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 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie ADDRESSES: E:\FR\FM\08APN1.SGM 08APN1 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

Agencies

[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 18029-18030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7022]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0565]


Agency Information Collection Activities; Submission for Office 
of Managment and Budget Review; Comment Request; State Petitions for 
Exemption From Preemption

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 comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie

[[Page 18030]]

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.

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.

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 Sec.  100.1(d) enables FDA to determine 
whether the State food labeling or standard-of-identity 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 60-day 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 Sec.  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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency per     Total Annual      Hours per
                 21 CFR Section                      No. of Respondents              Response             Responses       Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.1(d)                                                              1                          1               1              40                40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  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 Sec.  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
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