65FR38290 Agency Information Collection Activities; Submission for OMB Review; Comment Request; General Licensing Provisions: Changes to an Approved Application, Labeling, and Revocation and Suspension
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Posting-number: Volume 65, Issue 119, Page 38290
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Notices]
[Page 38290-38292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-0726]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; General Licensing Provisions: Changes to an
Approved Application, Labeling, and Revocation and Suspension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by July
20, 2000.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Wendy Taylor, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
General Licensing Provisions: Changes to an Approved Application,
Labeling, and Revocation and Suspension (OMB Control Number 0910-
0315)--Extension
Under Section 351 of the Public Health Services Act (PHS Act) (42
U.S.C. 262), manufacturers of biological products must submit a license
application for FDA review and approval prior to 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 meet 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), Sec. 601.2(a) requires a
manufacturer of a biological product to submit an application with
accompanying information, including labeling information, to FDA for
approval to market a product in interstate commerce. Section 601.12(b),
(c), and (d) requires applicants to follow specific procedures in
informing FDA of each change, established in an approved license
application, in the product, production process, quality controls,
equipment, facilities, or responsible personnel depending on the
potential for the change to have a substantial, moderate, minimal or no
adverse effect on the safety or effectiveness of the product. Section
601.12(e) requires applicants to submit a protocol, or change to a
protocol, as a supplement requiring FDA approval prior to distributing
the product. Section 601.12(f)(1), (f)(2), and (f)(3) requires
applicants to follow specific procedures in reporting labeling changes
to FDA. Section 601.12(f)(4) requires advertising and promotional
labeling and any changes to be reported to FDA. Section 601.45 requires
applicants to submit to the agency for consideration, during the
preapproval review period, copies of all promotional materials,
including promotional labeling as well as advertisements. In addition
to Secs. 601.2 and 601.12, there are other regulations that relate to
certain information submitted in a license application or supplement as
follows: Part 640 (21 CFR part 640), specifically Secs. 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); 21 CFR 660.51(a)(4) and 680.1(b)(2)(iii) and (c). The burden
associated with the information collection requirements in these
regulations is included in the burden estimate for Sec. 601.2, reported
under OMB Control No. 0910-0427, and Sec. 601.12 in table 1 of this
document. Sections 600.15(b) and 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 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) requests that licensees submit
to FDA a written statement intended to show that studies adequate and
appropriate to resolve questions raised about a biological product have
been undertaken for a product if designated as requiring further study
under the reclassification procedures. Section 601.5(a) requires a
licensee to give notice of its intention to discontinue manufacture of
a product or all products. Section 601.6(a) requires the licensee to
notify selling agents and distributors upon suspension of its license,
and provide FDA with records of such notification.
Form FDA 2567 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 the Center for Biologics
Evaluation and Research (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 the Center for Drug Evaluation
and Research. In August of 1998, FDA revised and harmonized Form FDA
2253 to enable the form to 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.
The number of respondents is based on the estimated annual number
of manufacturers that submitted the required information to FDA. There
are an estimated 350 licensed biologics manufacturers. However, not all
manufacturers will have any submissions in a given year and some may
have multiple submissions. The
[[Page 38291]]
total annual responses is based on the estimated number of submissions
(i.e., license applications, labeling and other supplements, protocols,
advertising and promotional labeling, notifications) received annually
by FDA. The rate of submissions are not expected to change
significantly in the next few years. The hours per response are based
on past FDA experience with the various submissions or notifications.
Additional information regarding these estimates is provided below as
necessary.
Under Sec. 601.2(a), the total annual responses is based on the
numbers of applications submitted to FDA for approval to market a
biological product. The estimated burden hours include the time
required to fill out the form and collate the documentation. The
estimated burden hours to prepare the labeling information submitted
with a license application are included in the burden hours to submit a
license application that are reported under OMB Control No. 0910-0427.
Under Sec. 601.12(f)(1), (f)(2), and (f)(3), the estimated burden
hours include the time to prepare the supplement, fill out the form,
and collate the documentation.
Under Secs. 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. In fiscal year 1999, CBER
received 3,784 submissions of advertising and promotional labeling from
114 manufacturers. FDA estimates that approximately 55 percent of those
submissions were received with Form FDA 2567 resulting in an estimated
2,081 submissions by 63 manufacturers. The estimated burden hours
include the time to prepare the submission, fill out the form, and
collate the documentation. The burden hours for the remaining
submissions received using Form FDA 2253 are reported under OMB Control
No. 0910-0376.
Under Secs. 601.12(b) through (d), and 601.12(e), the estimated
burden hours include the time to prepare the appropriate supplement or
protocol, respectively, and collate the documentation.
Under Secs. 600.15(b) (21 CFR 600.15(b)) and 610.53(d), FDA
receives very few requests for an exemption or modification to the
requirements, therefore, FDA has estimated one respondent per year in
table 1 of this document to account for the rare instance in which a
request may be made. The estimated burden hours include the time to
prepare the request for modification or exemption.
Under Sec. 601.25(b)(3), FDA estimates no burden for this
regulation because all requested data and information had been
submitted by 1974. Under Sec. 601.26(f), FDA estimates no burden for
this regulation because there are no products designated to require
further study and none are predicted in the future. However, 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 find further study necessary. As a result, any changes
to product labeling would be reported under Sec. 601.12. The
information collection requirements for Sec. 601.12 are reported under
OMB control number 0910-0315.
Under Sec. 601.5(a), the total annual responses are based on the
estimated annual number of notifications received by FDA to discontinue
either an establishment and/or product license(s). The estimated burden
hours include the time to prepare and submit a letter of
discontinuance.
Under Sec. 601.6(a), the number of respondents (21) is based on FDA
estimates that establishments would need to notify an average of 20
selling agents and distributors of such suspension, and provide FDA
with the records of such notification. The number of respondents is
based on the estimated annual number of suspensions by FDA of an
establishment or product license(s). The estimated burden hours
includes the time to prepare a notification letter and submit record of
such notification to FDA.
In the Federal Register of March 7, 2000 (65 FR 12011), the agency
requested comments on the proposed collections of information. No
significant comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual
21 CFR section Form FDA No. No. of frequency per Total annual Hours per Total hours
respondents response responses response
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601.2(a) 2567 and 356h 17 3.71 63 2 126
\2\
601.12(f)(1) 2567 12 1 12 40 480
601.12(f)(2) 2567 10 1 10 20 200
601.12(f)(3) 2567 70 1.43 100 10 1,000
601.12(f)(4) 2567 63 33.03 2,081 10 20,810
and 601.45
601.12(b)(1) 356h \2\ 190 4.75 903 80 72,240
and (b)(3)
601.12(c)(1) 356h \2\ 98 2.60 255 50 12,750
and (c)(3)
601.12(c)(5) 356h \2\ 34 1.21 41 50 2,050
601.12(d) 356h \2\ 166 1.37 227 10 2,270
601.12(e) 356h \2\ 14 1.43 20 20 400
600.15(b) 356h \2\ 1 1 1 8 8
610.53(d) 356h \2\ 1 1 1 8 8
601.25(b)(3) NA 0 0 0 0 0
601.26(f) NA 0 0 0 0 0
601.5(a) NA 33 1 33 .33 11
601.6(a) NA 2 10.50 21 .33 7
Total 112,360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The burden hours for the use of Form FDA 356h are reported under OMB Control No. 0910-0427.
[[Page 38292]]
Dated: June 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-15429 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F