[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4081-4086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1439]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0019]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports, and Forms FDA
356h and 2567
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
[[Page 4082]]
public comment in response to the notice. This notice solicits comments
on the collection of information relating to general licensing
provisions for biologics license applications (BLAs), changes to an
approved application, labeling, revocation and suspension,
postmarketing studies status reports, and Forms FDA 356h and 2567.
DATES: Submit written or electronic comments on the collection of
information by March 29, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
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.
General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 (OMB
Control Number 0910-0338)--Extension
Under section 351 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 262), manufacturers of biological products must submit a
license application for FDA review and approval before marketing a
biological product in interstate commerce. Licenses may be issued only
upon showing that the establishment and the products for which a
license is desired meets standards prescribed in regulations designed
to ensure the continued safety, purity, and potency of such products.
All such licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
Section 130(a) of the Food and Drug Administration Modernization
Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic
Act (the act) by adding a new provision (section 506B of the act (21
U.S.C. 356b)) requiring reports of postmarketing studies for approved
human drugs and licensed biological products. Section 506B of the act
provides FDA with additional authority to monitor the progress of
postmarketing studies that applicants have made a commitment to conduct
and requires the agency to make publicly available information that
pertains to the status of these studies. Under section 506B(a) of the
act, applicants that have committed to conduct a postmarketing study
for an approved human drug or licensed biological product must submit
to FDA a status report of the progress of the study or the reasons for
the failure of the applicant to conduct the study. This report must be
submitted within 1 year after the U.S. approval of the application and
then annually until the study is completed or terminated.
A summary of additional collection of information requirements
follows:
Section 601.2(a) requires a manufacturer of a biological product to
submit an application on forms prescribed for such purposes with
accompanying data and information, including certain labeling
information, to FDA for approval to market a product in interstate
commerce. The container and package labeling requirements are provided
under Sec. Sec. 610.60 through 610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is included in the estimate under
Sec. 601.2(a) in table 1 of this document.
Section 601.5(a) requires a manufacturer to submit to FDA notice of
its intention to discontinue manufacture of a product or all products.
Section 601.6(a) requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such
notification.
Section 601.12(a)(2) requires, generally, that the holder of an
approved BLA must assess the effects of a manufacturing change before
distributing a biological product made with the change. Section
601.12(a)(4) requires, generally, that the applicant must promptly
revise all promotional labeling and advertising to make it consistent
with any labeling changes implemented. Section 601.12(a)(5) requires
the applicant to include a list of all changes contained in the
supplement or annual report; for supplements, this list must be
provided in the cover letter. The burden estimates for Sec.
601.12(a)(2) are included in the estimates for supplements (Sec.
601.12(b) and (c)) and annual reports (Sec. 601.12(d)). The burden
estimates for Sec. 601.12(a)(4) are included in the estimates under
Sec. 601.12(f)(4) in table 1 of this document.
Section 601.12(b)(1), (b)(3), (c)(1), (c)(3), (c)(5), (d)(1), and
(d)(3) requires applicants to follow specific procedures to submit
information to FDA of any changes, in the product, production process,
quality controls, equipment, facilities, or responsible personnel
established in an approved license application. The appropriate
procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec. 601.12(b)(4) is minimal and
included in the estimate under Sec. 601.12(b)(1) and (b)(3) in table 1
of this document.
Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3)
requires applicants to follow specific procedures to report certain
[[Page 4083]]
labeling changes to FDA. Section 601.12(f)(4) requires applicants to
report to FDA advertising and promotional labeling and any changes.
Under Sec. 601.14, the content of labeling required in 21 CFR
201.100(d)(3) must be in electronic format and in a form that FDA can
process, review, and archive. This requirement is in addition to the
provisions of Sec. Sec. 601.2(a) and 601.12(f). The burden estimate
for Sec. 601.14 is minimal and included in the estimate under
Sec. Sec. 601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and (f)(3)
(labeling supplements and annual reports) in table 1 of this document.
Section 601.45 requires applicants of biological products for
serious or life-threatening illnesses to submit to the agency for
consideration, during the pre-approval review period, copies of all
promotional materials, including promotional labeling as well as
advertisements.
In addition to Sec. Sec. 601.2 and 601.12, there are other
regulations in parts 640, 660, and 680 (21 CFR parts 640, 660, and 680)
that relate to information to be submitted in a license application or
supplement for certain blood or allergenic products as follows:
Sec. Sec. 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c),
640.64(c), 640.74(a) and (b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) and
(d). In table 1 of this document, the burden associated with the
information collection requirements in these regulations is included in
the burden estimate for Sec. Sec. 601.2 and/or 601.12. A regulation
may be listed under more than one paragraph of Sec. 601.12 due to the
type of category under which a change to an approved application may be
submitted.
There are also additional container and/or package labeling
requirements for certain licensed biological products including: Sec.
640.70(a) for Source Plasma; Sec. 640.74(b)(3) and (4) for Source
Plasma Liquid; Sec. 640.84(a) and (c) for Albumin; Sec. 640.94(a) for
Plasma Protein Fraction; Sec. 660.2(c) for Antibody to Hepatitis B
Surface Antigen; Sec. 660.28(a), (b), and (c) for Blood Grouping
Reagent; Sec. 660.35(a), (c) through (g), and (i) through (m) for
Reagent Red Blood Cells; Sec. 660.45 for Hepatitis B Surface Antigen;
and Sec. 660.55(a) and (b) for Anti-Human Globulin. The burden
associated with the additional labeling requirements for submission of
a license application for these certain biological products is minimal
because the majority of the burden is associated with the requirements
under Sec. Sec. 610.60 through 610.65 or Sec. 809.10 (21 CFR 809.10).
Therefore, the burden estimates for these regulations are included in
the estimate under Sec. Sec. 610.60 through 610.65 in table 1 of this
document. The burden estimates associated with Sec. 809.10 are
approved under OMB Control No. 0910-0485.
Section 601.25(b) requests interested persons to submit, for review
and evaluation by an advisory review panel, published and unpublished
data and information pertinent to a designated category of biological
products that have been licensed prior to July 1, 1972. Section
601.26(f) requires that licensees submit to FDA a written statement
intended to show that studies adequate and appropriate to resolve the
questions raised about a biological product have been undertaken for a
product if designated as requiring further study under the
reclassification procedures. Under Sec. 601.25(b), FDA estimates no
PRA burden for this regulation, and therefore this regulation is not
included in table 1 of this document. Under section 601.26(f), FDA
estimates no burden for this regulation since there are no products
designated to require further study and none are predicted in the
future. However, FDA is using an estimate of one for calculation
purposes. Based on the possible reclassification of a product, the
labeling for the product may need to be revised, or a manufacturer, on
its own initiative, may deem it necessary for further study. As a
result, any changes to product labeling would be reported under the
appropriate paragraph of Sec. 601.12.
Section 601.27(a) requires that applications for new biological
products contain data that are adequate to assess the safety and
effectiveness of the biological product for the claimed indications in
pediatric subpopulations, and to support dosing and administration
information. Section 601.27(b) provides that an applicant may request a
deferred submission of some or all assessments of safety and
effectiveness required under Sec. 601.27(a) until after licensing the
product for use in adults. Section 601.27(c) provides that an applicant
may request a full or partial waiver of the requirements under Sec.
601.27(a) with adequate justification. The burden estimates for Sec.
601.27(a) are included in the burden estimate under Sec. 601.2(a) in
table 1 of this document since these regulations deal with information
to be provided in an application.
Section 601.28 requires sponsors of licensed biological products to
submit the information in Sec. 601.28(a), (b), and (c) to the Center
for Biologics Evaluation and Research (CBER) or the Center for Drug
Evaluation and Research (CDER) each year, within 60 days of the
anniversary date of approval of the license. Section 601.28(a) requires
sponsors to submit to FDA a brief summary stating whether labeling
supplements for pediatric use have been submitted and whether new
studies in the pediatric population to support appropriate labeling for
the pediatric population have been initiated. Section 601.28(b)
requires sponsors to submit to FDA an analysis of available safety and
efficacy data in the pediatric population and changes proposed in the
labeling based on this information. Section 601.28(c) requires sponsors
to submit to FDA a statement on the current status of any postmarketing
studies in the pediatric population performed by, on or behalf of, the
applicant. If the postmarketing studies were required or agreed to, the
status of these studies is to be reported under Sec. 601.70 rather
then under this section.
Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of in vivo radiopharmaceuticals. The burden estimates for
Sec. Sec. 601.33 through 601.35 are included in the burden estimate
under Sec. 601.2(a) in table 1 of this document since these
regulations deal with information to be provided in an application.
Section 601.70(b) requires each applicant of a licensed biological
product to submit annually a report to FDA on the status of
postmarketing studies for each approved product application. Each
annual postmarketing status report must be accompanied by a completed
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB Control No.
0910-0001). Under Sec. 601.70(d), two copies of the annual report
shall be submitted to FDA.
Sections 601.91 through 601.94 concerns biological products for
which human efficacy studies are not ethical or feasible. Section
601.91(b)(3) requires applicants to prepare and provide labeling with
relevant information to patients or potential patients for biological
products approved under part 601, subpart H when human efficacy studies
are not ethical or feasible (or based on evidence of effectiveness from
studies in animals). Section 601.93 provides that biological products
approved under subpart H are subject to the postmarketing recordkeeping
and safety reporting applicable to all approved biological products.
Section 601.94 requires applicants under subpart H to submit to the
agency for consideration during preapproval review period copies of all
promotional materials including promotional labeling as well as
advertisements.
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Under Sec. 601.93, any potential postmarketing reports and/or
recordkeeping burdens would be included under the adverse experience
reporting (AER) requirements under part 600 (21 CFR part 600) (OMB
Control No. 0910-0308). Therefore, any burdens associated with these
requirements would be reported under the AER information collection
requirements (OMB Control No. 0910-0308).
Section 610.9(a) requires the applicant to present certain
information, in the form of a license application or supplement to the
application, for a modification of any particular test method or
manufacturing process or the conditions which it is conducted under the
biologics regulations. The burden estimate for Sec. 610.9(a) is
included in the estimate under Sec. Sec. 601.2(a) and 601.12(b) and
(c) in table 1 of this document.
Section 610.11(g)(2) provides that a manufacturer of certain
biological products may request an exemption from the general safety
test (GST) requirements contained in subpart H. Under Sec.
610.11(g)(2), FDA requires only those manufacturers of biological
products requesting an exemption from the GST to submit additional
information as part of a license application or supplement to an
approved license application. Therefore, the burden estimate for Sec.
610.11(g)(2) is included in the estimate under Sec. Sec. 601.2(a) and
601.12(b) in table 1 of this document.
Section 640.120 requires licensed establishments to submit a
request for an exception or alternative to any requirement in the
biologics regulations regarding blood, blood components, or blood
products. A request for an exception or alternative must be submitted
in accordance with Sec. 601.12; therefore the burden estimate for
Sec. 640.120 is included in the estimate under Sec. 601.12(b) in
table 1 of this document.
Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
Sections 600.15(b) and 610.53(d) (21 CFR 610.53(d)) require the
submission of a request for an exemption or modification regarding the
temperature requirements during shipment and from dating periods,
respectively, for certain biological products. Section 606.110(b) (21
CFR 606.110(b)) requires the submission of a request for approval to
perform plasmapheresis of donors who do not meet certain donor
requirements for the collection of plasma containing rare antibodies.
Under Sec. Sec. 600.15(b), 610.53(d), and 606.110(b), a request for an
exemption or modification to the requirements would be submitted as a
supplement. Therefore, the burden hours for any submissions under
Sec. Sec. 600.15(b), 610.53(d), and 606.110(b) are included in the
estimates under Sec. 601.12(b) in table 1 of this document.
In July 1997, FDA revised Form FDA 356h ``Application to Market a
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize
application procedures between CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. The checklist helps to ensure that the application
is complete and contains all the necessary information, so that delays
due to lack of information may be eliminated. The form provides key
information to FDA for efficient handling and distribution to the
appropriate staff for review. The estimated burden hours for
nonbiological product submissions to CDER using FDA Form 356h are
approved under OMB Control No. 0910-0001.
Form FDA 2567 ``Transmittal of Labels and Circulars'' is used by
manufacturers of licensed biological products to submit labeling (e.g.,
circulars, package labels, container labels, etc.) and labeling changes
for FDA review and approval. The labeling information is submitted with
the form for license applications, supplements, or as part of an annual
report. Form FDA 2567 is also used for the transmission of
advertisements and promotional labeling. Form FDA 2567 serves as an
easy guide to assure that the manufacturer has provided the information
required for expeditious handling of their labeling by CBER. For
advertisements and promotional labeling, manufacturers of licensed
biological products may submit to CBER either Form FDA 2567 or 2253.
Form FDA 2253 was previously used only by drug manufacturers regulated
by CDER. In August of 1998, FDA revised and harmonized Form FDA 2253 so
the form may be used to transmit specimens of promotional labeling and
advertisements for biological products as well as for prescription
drugs and antibiotics. The revised, harmonized form updates the
information about the types of promotional materials and the codes that
are used to clarify the type of advertisement or labeling submitted;
clarifies the intended audience for the advertisements or promotional
labeling (e.g., consumers, professionals, news services); and helps
ensure that the submission is complete. Form FDA 2253 is approved under
OMB Control No. 0910-0001.
Under table 1 of this document, the number of respondents is based
on the estimated annual number of manufacturers that submitted the
required information to FDA or the number of submissions FDA received
in fiscal year 2008. Based on information obtained from FDA's database
systems, there are an estimated 301 licensed biologics manufacturers.
The total annual responses are based on the estimated number of
submissions (i.e., license applications, labeling and other
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. Based
on previous estimates, the rate of submissions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry and past FDA experience with
the various submissions or notifications. The hours per response
include the time estimated to prepare the various submissions or
notifications to FDA, and, as applicable, the time required to fill out
the appropriate form and collate the documentation. Additional
information regarding these estimates is provided in this document as
necessary.
Under Sec. Sec. 601.2 and 601.12, the estimated hours per response
are based on the average number of hours to submit the various
submissions. The estimated average number of hours is based on the
range of hours to complete a very basic application or supplement and a
complex application or supplement.
Under Sec. 601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license.
Under Sec. Sec. 601.12(f)(4) and 601.45, manufacturers of
biological products may use either Form FDA 2567 or Form FDA 2253 to
submit advertising and promotional labeling. Based on information
obtained from FDA's database system, there were an estimated 4,452
submissions of advertising and promotional labeling. FDA estimates that
approximately 15 percent of those submissions were received with Form
FDA 2567 and 85 percent were received with Form 2253.
Under Sec. Sec. 601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather,
[[Page 4085]]
complete, and submit the appropriate information for each postmarketing
status report (approximately two to four studies per report) and the
accompanied transmittal Form FDA 2252. Included in these 24 hours is
the time necessary to prepare and submit two copies of the annual
progress report of postmarketing studies to FDA under Sec. 601.70(d).
Under Sec. Sec. 601.91 through 601.94, FDA expects to receive very
few applications for these products; however, for calculation purposes,
FDA is estimating the annual submission of one application. Under
Sec. Sec. 601.93(b)(3) and 601.94, FDA estimates 240 hours for a
manufacturer of a new biological product to develop patient labeling,
and to submit the appropriate information and promotional labeling to
FDA. The majority of the burden for developing the patient labeling is
included under the reporting requirements for Sec. 601.94, therefore
minimal burden is calculated for providing the guide to patients under
Sec. 601.91(b)(3).
There were a total of 5,338 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Form FDA No. Respondents per Response Responses Response Total Hours
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601.2(a)\2\ and 610.60 through 610.65\3\ 2567/356h 23 2 46 860 39,560
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601.5(a) N/A 11 3 33 20 minutes 11
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601.6(a) N/A 1 21 21 20 minutes 7
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601.12(a)(5) N/A 802 9 7,218 1 7,218
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601.12(b)(1), (b)(3), and (e)\4\ 356h\2\ 166 5 830 80 66,400
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601.12(c)(1) and (c)(3)\5\ 356h\2\ 141 5 705 50 35,250
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601.12(c)(5) 356h\2\ 42 5 210 50 10,500
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601.12(d)(1), (d)(3), and (f)(3)\7\ 356h\2\ 246 3 738 23 16,974
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601.12(f)(1)\6\ 2567 112 2 224 40 8,960
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601.12(f)(2)\6\ 2567 53 3 159 20 3,180
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601.12(f)(4) and 601.45 2567/2253 42 106 4,452 10 44,520
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601.26(f) N/A 1 1 1 1 1
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601.27(b) N/A 6 1 6 24 144
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601.27(c) N/A 10 1 10 8 80
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601.70(b), (d), and 601.28 2252 39 2 78 24 1,872
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601.91(b)(3) and 601.94 N/A 1 1 1 240 240
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680.1(c) N/A 9 1 9 2 18
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680.1(b)(3)(iv) N/A 1 1 1 2 2
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Amendments/Resubmissions 356h 314 17 5,338 20 106,760
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Total 341,697
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec. Sec. 610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec. 601.2(a).
\3\ The reporting requirements under Sec. Sec. 640.70(a), 640.74(b)(3) and (b)(4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
660.35(a), (c) through (g), and (i) through (m), 660.45, and 660.55(a) and (b) are included under Sec. Sec. 610.60 through 610.65.
\4\ The reporting requirements under Sec. Sec. 610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec. 601.12(b).
\5\ The reporting requirements under Sec. Sec. 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under Sec.
601.12(c).
\6\ The reporting requirement under Sec. 601.14 is included in the estimate under Sec. 601.12(f)(1) and (f)(2).
\7\ The reporting requirement under Sec. 601.14 is included in the estimate under Sec. 601.12(f)(3).
[[Page 4086]]
Under table 2, the estimated recordkeeping burden of 1 hour is
based on previous estimates for the recordkeeping requirements
associated with the AER system.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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601.91(b)(2)(iii) 1 1 1 1 1
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\1\ There are no capital costs or operating costs associated with this collection of information.
Dated: January 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1439 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S