posed for the biological product have been pre-
viously approved for the reference product. 
‘‘(E) Information to show that the route of 
administration, the dosage form, and the 
strength of the biological product are the same 
as those of the reference product. 
‘‘(F) Data demonstrating that the facility 
in which the biological product is manufactured, 
processed, packed, or held meets standards de-
signed to assure that the biological product con-
tinues to be safe, pure, and potent. 
‘‘(G) At the applicant’s option, publicly- 
available information regarding the Secretary’s 
previous determination that the reference prod-
uct is safe, pure, and potent. 
‘‘(H) Any additional data and information 
in support of the application, including publicly- 
available information with respect to the ref-
erence product or another biological product. 
‘‘(2) OTHER APPLICATIONS.—Any person, in-
cluding a person who has not conducted and does 
not have a right of reference to the studies in the 
application for a reference product, may submit an 
application under this paragraph for a biological 
product that differs from, or incorporates a change 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
to, the reference product with respect to one or more 
characteristics described in subparagraphs (A) 
through (E) of paragraph (1), including a difference 
in safety, purity, or potency, so long as the applica-
tion contains sufficient information to establish the 
safety, purity, and potency of the biological product 
relative to the reference product for its proposed 
condition or conditions of use. 
‘‘(3) FDA REVIEW OF ABBREVIATED BIOLOGI-
CAL PRODUCT APPLICATIONS.— 
‘‘(A) GUIDANCE
REGARDING
REVIEW
OF 
APPLICATIONS.—The Secretary shall issue guid-
ance for the individuals who review applications 
submitted under paragraph (1) or (2), which 
shall relate to promptness in conducting the re-
view, technical excellence, lack of bias and con-
flict of interest, and knowledge of regulatory 
and scientific standards, and which shall apply 
equally to all individuals who review such appli-
cations. 
‘‘(B) MEETINGS WITH SPONSORS AND AP-
PLICANTS.—The Secretary shall meet with a 
sponsor of an investigation or an applicant for 
approval of a comparable or interchangeable bi-
ological product under this subsection if the 
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS
sponsor or applicant makes a reasonable writ-
ten request for a meeting for the purpose of 
reaching agreement on the design and size of 
studies needed for approval of the application. 
The sponsor or applicant shall provide informa-
tion necessary for discussion and agreement on 
the design and size of such studies. Minutes of 
any such meeting shall be prepared by the Sec-
retary and made available to the sponsor or ap-
plicant. 
‘‘(C) AGREEMENTS.—Any agreement re-
garding the parameters of design and size of 
the studies of a biological product under this 
paragraph that is reached between the Sec-
retary and a sponsor or applicant shall be re-
duced to writing and made part of the adminis-
trative record by the Secretary. Such agreement 
shall not be changed after the testing begins, 
except— 
‘‘(i) with the written agreement of the 
sponsor or applicant; or 
‘‘(ii) pursuant to a decision, made in 
accordance with subparagraph (D) by the 
director of the reviewing division, that a 
substantial scientific issue essential to de-
VerDate Aug 31 2005 
23:25 Feb 17, 2007
Jkt 059200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1038.IH
H1038
hsrobinson on PROD1PC76 with BILLS