Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
ICR 200704-0910-004
OMB: 0910-0513
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0513 can be found here:
Applications for FDA Approval
to Market a New Drug: Patient Listing Requirements and Application
of 30-month Stays on Approval of Abbreviated New Drug Applications
Certifying That...
Extension without change of a currently approved collection
The proposal would amend FDA's patient
listing requirements for new drug applications (NDA's). The
proposal would clarify the types of patents that must and must not
be listed and revise the declaration that NDA applicants must
provide regarding their patents to help ensure that NDA applicants
list only appropriate patents. The proposal would also revise the
regulations regarding the effective date of approval for certain
abbreviated new drug applications (ANDA's) and certain applications
submitted under section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (505(b)(2) applications).
US Code:
21
USC 355(b)1 Name of Law: THe Federal Food, Drug, and Cosmetic
Act
US Code:
21 USC 505(c)(2) Name of Law: The Federal Food, Drug, and
Cosmetic Act
US Code:
21 USC 355(c)(2) Name of Law: THe Federal Food, Drug, and
Cosmetic Act
US Code:
21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and
Cosmetic Act
The information collection
burden for section 314.50(h) (citing section 314.53) and Forms 3542
and 3542a will decrease from the estimate we made in the June 2003
final rule for sections 314.50(a) through (f), (h), and (k), and
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). As stated earlier, certain sections of the June 2003 final
rule regarding the application of 30-month stays on approval of
certain ANDAs and certain other new drug applications, 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505(b)(2) applications, submitted under the act, were superseded by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 sections
314.52(a)(3) and 314.95(a)(3) (21 CFR 314.52(a)(3) and 21 CFR
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, sections 314.52(a)(3) and 314.95(a)(3), and certain
sections of the regulations, sections 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.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 3542a Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
FDA-3542a.doc
Applications for FDA Approval to Market a New Drug: Patient Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...