Proposed Information Collection Activity; Comment Request, 17925-17926 [2010-7984]

Download as PDF 17925 Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices contain patent information described under § 314.53. Section 314.53 requires that an applicant submitting an NDA, an amendment, or a supplement, except as provided in § 314.53(d)(2), submit on Forms 3542 and 3542a, the required patent information described in this section. Compliance with the information collection burdens under §§ 314.50(h) and 314.53 consists of submitting with an NDA, an amendment, or a supplement (collectively referred to as ‘‘application’’) the required patent declaration(s) on Form 3542a for each ‘‘patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product’’ (§ 314.53(b)). Such patents claim the drug substance (active ingredient), drug product (formulation and composition), or method of use. If a patent is issued after the application is filed with FDA but before the application is approved, the applicant must submit the required patent information on Form 3542a as an amendment to the application, within 30 days of the date of issuance of the patent. Within 30 days after the date of approval of an application, the applicant must submit Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use for listing in the Orange Book. In addition, for patents issued after the date of approval of an application, Form 3542 must be submitted within 30 days of the date of issuance of the patent. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section § 314.50 (citing § 314.53) No. of Respondents No. of Responses per Respondent Total Annual Responses Hours per Response Total Hours Form FDA 3542a 233 2.6 606 20 12,120 Form FDA 3542 154 2.6 400 5 2,000 Total Reporting Burden Hours: sroberts on DSKD5P82C1PROD with NOTICES 1 There 14,120 are no operating and maintenance costs or capital costs associated with this collection of information. The numbers of patents submitted to FDA for listing in the Orange Book in 2007, 2008, and 2009 were 268, 347, and 335, respectively, for an annual average of 317 (268 patents + 347 patents + 335 patents) / 3 years = 317 patents / year). Because many of these individual patents are included in multiple NDA submissions, there could be multiple declarations for a single patent. From our previous review of submissions, we believe that approximately 14 percent of the patents submitted are included in multiple NDA submissions, and thus require multiple patent declarations. Therefore, we estimate that 44 (317 patents x 14 percent) patents will be multiple listings, and there will be a total of 361 patents (317 patents + 44 patents = 361 patents) declared on Form FDA 3542. We approved 67, 73, and 77 NDAs in 2007, 2008, and 2009, respectively, of which approximately 71% submitted patent information for listing in the Orange Book. The remaining NDAs submitted Form 3542 as required and declared that there were no relevant patents. We also approved approximately 88, 96, and 62 NDA supplements in 2007, 2008, and 2009, respectively, for which submission of a patent declaration would be required. We estimate there will be 154 instances (based on an average of 72 NDA approvals and 82 supplement approvals per year) where an NDA holder would be affected by the patent declaration VerDate Nov<24>2008 16:26 Apr 07, 2010 Jkt 220001 requirements, and that each of these NDA holders would, on average, submit 2.6 declarations ((361 patent declarations + 45 no relevant patent declarations) / 154 instances = 2.6 declarations per instance) on Form FDA 3542. We filed 120, 113, and 118 NDAs in 2007, 2008, and 2009, respectively, and 145, 99, and 104 NDA supplements in 2007, 2008, and 2009, respectively, for which submission of a patent declaration would be required. We estimate there will be 233 instances (based on an average of 117 NDAs filed and 116 NDA supplements filed per year) where an NDA holder would be affected by the patent declaration requirements. We estimate, based on a proportional increase from the number of declarations for approved NDAs, that there will be an annual total of 606 declarations (233 instances x 2.6 declarations per instance = 606 declarations) on Form FDA 3542a submitted with these applications. Based upon information provided by regulated entities and other information, we previously estimated that the information collection burden associated with Sec. 314.50(h) (citing Sec. 314.53) and FDA Forms 3542a and 3542 will be approximately 20 hours and 5 hours per response, respectively. On December 3, 2008, FDA announced in the Federal Register (73 FR 73659) the availability of a draft guidance for industry entitled ‘‘Submission of Patent Information for PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Certain Old Antibiotics.’’ That draft guidance, if finalized, would provide information regarding FDA’s current thinking on the implementation of section 4(b)(1) of the Q1 Program Supplemental Funding Act (Public Law 110–379). Section 4(b)(1) of the Q1 Act requires submission to FDA of patent information by sponsors of certain NDAs containing old antibiotics. Estimates on the number of Forms FDA 3542a and 3542 that might be submitted in accordance with a finalized guidance have been included in table 1 of this document. Dated: April 2, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–7891 Filed 4–7–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: Interstate Administrative Subpoena. OMB No.: 0970–0152. Description: Section 452(a)(11) of the Social Security Act requires the Secretary of the Department of Health E:\FR\FM\08APN1.SGM 08APN1 17926 Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices and Human Services to promulgate a form for administrative subpoenas to be used in State child support enforcement programs to collect information for use in the establishment, modification and enforcement of child support orders in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the federal form for issuance of administrative subpoenas in interstate child support cases. Tribal IV–D agencies are not required to use this form but may choose to do so. OMB approval of this form is expiring in February 2011 and the Administration for Children and Families is requesting an extension of this form. Respondents: State, local or Tribal agencies administering a child support enforcement program under title IV–D of the Social Security Act. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Administrative Subpoena ................................................................................. 35,286 1 0.50 17,643 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 17,643 Instrument In compliance with the requirements of section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: April 5, 2010. Robert Sargis, Reports Clearance Officer. [FR Doc. 2010–7984 Filed 4–7–10; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Total burden hours OMB No.: 0970–0153. Description: Section 452(a)(11) of the Social Security Act requires the Secretary of Health and Human Services to promulgate a form for imposition of liens to be used by the State child support enforcement (Title IV–D) agencies in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the Federal form for imposition of liens in interstate child support cases. Tribal IV–D agencies are not required to use this form but may choose to do so. OMB approval of this form is expiring in February 2011 and the Administration for Children and Families is requesting an extension of this form. Respondents: State, local or Tribal agencies administering a child support enforcement program under title IV–D of the Social Security Act. Proposed Projects Title: Notice of Interstate Lien. ANNUAL BURDEN ESTIMATES Number of respondents Instrument sroberts on DSKD5P82C1PROD with NOTICES Notice of Lien ................................................................................................... Estimated Total Annual Burden Hours: 458,096. In compliance with the requirements of section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and VerDate Nov<24>2008 16:26 Apr 07, 2010 Jkt 220001 1,832,384 comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response 0.25 Total burden hours 458,096 The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17925-17926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: Interstate Administrative Subpoena.
    OMB No.: 0970-0152.
    Description: Section 452(a)(11) of the Social Security Act requires 
the Secretary of the Department of Health

[[Page 17926]]

and Human Services to promulgate a form for administrative subpoenas to 
be used in State child support enforcement programs to collect 
information for use in the establishment, modification and enforcement 
of child support orders in interstate cases. Section 454(9)(E) of the 
Social Security Act requires each State to cooperate with any other 
State in using the federal form for issuance of administrative 
subpoenas in interstate child support cases. Tribal IV-D agencies are 
not required to use this form but may choose to do so. OMB approval of 
this form is expiring in February 2011 and the Administration for 
Children and Families is requesting an extension of this form.
    Respondents: State, local or Tribal agencies administering a child 
support enforcement program under title IV-D of the Social Security 
Act.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Administrative Subpoena.........................          35,286               1            0.50          17,643
                                                 ---------------------------------------------------------------
    Estimated Total Annual Burden Hours.........  ..............  ..............  ..............          17,643
----------------------------------------------------------------------------------------------------------------

    In compliance with the requirements of section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Administration, Office of Information Services, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail 
address: infocollection@acf.hhs.gov. All requests should be identified 
by the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

    Dated: April 5, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-7984 Filed 4-7-10; 8:45 am]
BILLING CODE 4184-01-P