[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Pages 32099-32101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0215]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Applications for Food and Drug Administration Approval 
to Market a New Drug: Patent Submission and Listing Requirements and 
Application of 30-Month Stays on Approval of Abbreviated New Drug 
Applications Certifying That a Patent Claiming a Drug Is Valid or Will 
Not Be Infringed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reporting requirements for 
submission and listing of patent information associated with a new drug 
application (NDA), an amendment, or a supplement.

DATES: Submit written or electronic comments on the collection of 
information by August 1, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://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: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

[[Page 32100]]

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.

Applications for FDA Approval to Market a New Drug: Patent Submission 
and Listing Requirements and Application of 30-Month Stays on Approval 
of Abbreviated NDAs Certifying That a Patent Claiming a Drug Is Invalid 
or Will Not Be Infringed (OMB Control Number 0910-0513)--Extension

    FDA is requesting that OMB revise and extend approval under the PRA 
for the information collection contained in the final rule entitled 
``Applications for FDA Approval to Market a New Drug: Patent Submission 
and Listing Requirements and Application of 30-Month Stays on Approval 
of Abbreviated New Drug Applications Certifying That a Patent Claiming 
a Drug Is Invalid or Will Not Be Infringed'' (68 FR 36676, June 18, 
2003) (the June 2003 final rule).
    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 355(b)(1)) requires all NDA applicants to file, as part 
of the NDA, ``the patent number and the expiration date of any patent 
which claims the drug for which the applicant submitted the application 
or which claims a method of using such drug and with respect to which a 
claim of patent infringement could reasonably be asserted if a person 
not licensed by the owner engaged in the manufacture[,] use, or sale of 
the drug.'' Section 505(c)(2) of the act imposes a similar patent 
submission obligation on holders of approved NDAs when the NDA holder 
could not have submitted the patent information with its application. 
Under section 505(b)(1) of the act, we publish patent information after 
approval of an NDA application in the list entitled ``Approved Drug 
Products with Therapeutic Equivalence Evaluations'' (the Orange Book). 
If patent information is submitted after NDA approval, section 
505(c)(2) of the act directs us to publish the information upon its 
submission.
    The June 2003 final rule clarified the types of patent information 
that must and must not be submitted to FDA as part of an NDA, an 
amendment, or a supplement. The June 2003 final rule also required 
persons submitting an NDA, an amendment, or a supplement, or submitting 
information on a patent after NDA approval, to make a detailed patent 
declaration using required forms (Form FDA 3542a and Form FDA 3542).
    Certain sections of the June 2003 final rule regarding the 
application of 30-month stays on approval of certain abbreviated new 
drug applications (ANDAs) and certain other NDAs, known as 505(b)(2) 
applications, submitted under the act, were superseded by the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003, signed 
December 8, 2003. The affected sections of the regulations issued in 
the June 2003 final rule--under part 314 (21 CFR part 314), Sec. Sec.  
314.52(a)(3) and 314.95(a)(3)--were revoked by the technical amendment 
to the June 2003 final rule, published in the Federal Register of March 
10, 2004 (69 FR 11309). Accordingly, FDA's request to extend approval 
under the PRA for the collection of information contained in the June 
2003 final rule is revised to exclude the revoked sections of the 
regulations, Sec. Sec.  314.52(a)(3) and 314.95(a)(3), and certain 
sections of the regulations, Sec. Sec.  314.50(i)(1)(i) and 
314.94(a)(12), which were included in the estimated annual reporting 
burden to describe an information collection burden associated with the 
revoked sections of the regulations.
    The reporting burden for submitting an NDA, an amendment, or 
supplement in accordance with Sec.  314.50(a) through (f), and (k) has 
been estimated by FDA and the collection of information has been 
approved by OMB under OMB control number 0910-0001, most recently until 
May 31, 2008 (70 FR 35099, June 16, 2005). In addition, the reporting 
burden associated with the previously-referenced Sec. Sec.  
314.50(i)(1)(i) and 314.94(a)(12), regarding patent certification 
requirements for 505(b)(2) applications and ANDAs also has been 
estimated and included within the collection of information approved by 
OMB under OMB control number 0910-0001. We are not re-estimating these 
approved burdens in this document. Only the reporting burdens 
associated with patent submission and listing in the final rule are 
estimated in this document.
    The information collection reporting requirements are as follows:
    Section 314.50(h) requires that an NDA, an amendment, or a 
supplement contain patent information described under Sec.  314.53.
    Section 314.53 requires that an applicant submitting an NDA, an 
amendment, or a supplement, except as provided in Sec.  314.53(d)(2), 
submit on FDA Forms 3542 and 3542a, the required patent information 
described in the section.
    Compliance with the information collection burdens under Sec. Sec.  
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 FDA 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'' (Sec.  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 FDA 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 FDA 3542 for each patent that claims the 
drug substance (active ingredient), drug product (formulation and 
composition), or approved method of use for listing in

[[Page 32101]]

the Orange Book. In addition, for patents issued after the date of 
approval of an application, Form FDA 3542 must be submitted within 30 
days of the date of issuance of the patent.
    Following publication of the June 2003 final rule, the numbers of 
patents submitted to FDA for listing in the Orange Book in 2004 and 
2005 were 244 and 295, respectively, for an annual average of 269.5 
((244 patents + 295 patents) / 2 years = 269.5 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 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 38 (269.5 patents x 14 percent) patent declarations 
will be multiple listings, and there will be 308 (269.5 declarations + 
38 declarations = 307.5 declarations) total annual patent declarations 
on Form FDA 3542.
    As we approved 113 and 78 NDAs in 2004 and 2005, respectively, we 
assume there will be 96 ((113 approvals + 78 approvals) / 2 years = 
95.5 approvals / year) instances where an NDA holder would be affected 
by the patent declaration requirements, and that each of these NDA 
holders would, on average, submit 3.2 (308 declarations / 96 instances 
= 3.2 declarations per instance) declarations on Form FDA 3542.
    As we received 112 and 115 NDAs in 2004 and 2005, respectively, we 
assume there will be 114 ((112 applications + 115 applications) / 2 
years = 113.5 applications / year) instances 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 365 (114 instances x 3.2 
declarations per instance = 365 declarations) declarations on Form FDA 
3542a submitted with these applications.
    The previous burden hour estimate of 1,684 hours for Sec.  314.50 
covered paragraphs (a) through (f), (k), and (h) (citing Sec.  314.53) 
and FDA Forms 3542 and 3542a (see June 2003 final rule), due to the 
difficulty in determining what proportion of the burden hour estimate 
for Sec.  314.50(a) through (f), (h), and (k), was attributable to 
patent declarations. Based upon information provided by regulated 
entities and other information, we estimate 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.
    Thus, the information collection burden for Sec.  314.50(h) (citing 
Sec.  314.53) and FDA Forms 3542 and 3542a will decrease from the 
estimate we made in the June 2003 final rule for Sec.  314.50(a) 
through (f), (h), and (k), and FDA Forms 3542 and 3542a of 498,464 
hours to 8,840 hours ((365 annual responses x 20 hours per response = 
7,300 hours) + (308 annual responses x 5 hours per response = 1,540 
hours) = 8,840 total hours).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         No. of Responses       Total Annual        Hours per
                       FDA Form                            Respondents        per Respondent         Responses           Response         Total Hours
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Form FDA 3542a                                                        114                   3.2                365                 20              7,300
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Form FDA 3542                                                          96                   3.2                308                  5              1,540
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Total                                                                                                                                              8,840
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8570 Filed 6-1-06; 8:45 am]
BILLING CODE 4160-01-S