Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols, 37714-37715 [E9-17978]
Download as PDF
<![CDATA[
37714
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices
children’s heart health, allocating
resources for the campaign to provide
support to overcome perceived barriers;
Frequency of Response: One-time
survey; Affected Public: Individuals or
households; and Type of Respondents:
Parents and caregivers of children ages
0–7. The annual reporting burden is as
follows: Estimated Number of
Respondents: 1,175; Estimated Number
of Responses per Respondent: 1;
Average Burden Hours per Response:
.167; and Estimated Total Annual
Burden Hours Requested: 196.23. There
are no Capital Costs, Operating Costs
and/or Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
mstockstill on DSKH9S0YB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Amy Pianalto,
National Heart, Lung, and Blood
Institute, NIH, 31 Center Drive, Building
31A, Room 4A10, Bethesda, MD 20892;
or call non-toll-free number 301–594–
2093 or e-mail request, including your
address, to pianaltoa@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: July 21, 2009.
Amy Pianalto,
Office of Communications and Legislative
Activities, NHLBI, National Institutes of
Health.
[FR Doc. E9–18071 Filed 7–28–09; 8:45 am]
BILLING CODE 4140–01–P
VerDate Nov<24>2008
18:30 Jul 28, 2009
Jkt 217001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0097]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Request for
Samples and Protocols
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 28,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0206. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Request for Samples and Protocols—
(OMB Control Number 0910–0206)—
Extension
Under section 351 of the Public
Health Service Act (42 U.S.C. 262), FDA
has the responsibility to issue
regulations that prescribe standards
designed to ensure the safety, purity,
and potency of biological products and
to ensure that the biologics licenses for
such products are only issued when a
product meets the prescribed standards.
Under § 610.2 (21 CFR 610.2), the
Center for Biologics Evaluation and
Research (CBER) or the Center for Drug
Evaluation and Research may at any
time require manufacturers of licensed
biological products to submit to FDA
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
samples of any lot along with the
protocols showing the results of
applicable tests prior to distributing the
lot of the product. In addition to § 610.2,
there are other regulations that require
the submission of samples and protocols
for specific licensed biological products:
§§ 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21
CFR 660.36) (Reagent Red Blood Cells);
and 660.46 (21 CFR 660.46) (Hepatitis B
Surface Antigen). Section 660.6(a)
provides requirements for the frequency
of submission of samples from each lot
of Antibody to Hepatitis B Surface
Antigen product, and § 660.6(b)
provides the requirements for the
submission of a protocol containing
specific information along with each
required sample. For § 660.6 products
subject to official release by FDA, one
sample from each filling of each lot is
required to be submitted along with a
protocol consisting of a summary of the
history of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After official release is no longer
required, one sample along with a
protocol is required to be submitted at
90-day intervals. In addition, samples,
which must be accompanied by a
protocol, may at any time be required to
be submitted to CBER if continued
evaluation is deemed necessary.
Section 660.36(a) requires, after each
routine establishment inspection by
FDA, the submission of samples from a
lot of final Reagent Red Blood Cell
product along with a protocol
containing specific information. Section
660.36(a)(2) requires that a protocol
contain information including, but not
limited to, manufacturing records,
certain test records, and identity test
results. Section 660.36(b) requires a
copy of the antigenic constitution
matrix specifying the antigens present
or absent to be submitted to the CBER
Director at the time of initial
distribution of each lot. Section
660.46(a) contains requirements as to
the frequency of submission of samples
from each lot of Hepatitis B Surface
Antigen product, and § 660.46(b)
contains the requirements as to the
submission of a protocol containing
specific information along with each
required sample. For § 660.46 products
subject to official release by FDA, one
sample from each filling of each lot is
required to be submitted along with a
protocol consisting of a summary of the
history of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After notification of official
release is received, one sample along
E:\FR\FM\29JYN1.SGM
29JYN1
37715
Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices
with a protocol is required to be
submitted at 90-day intervals. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to
CBER if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the safety, purity, or
potency of a product because of the
potential lot-to-lot variability of a
product produced from living
organisms. In cases of certain biological
products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological
products) that are known to have lot-tolot consistency, official lot release is not
normally required. However,
submissions of samples and protocols of
these products may still be required for
surveillance, licensing, and export
purposes, or in the event that FDA
obtains information that the
manufacturing process may not result in
consistent quality of the product.
The following burden estimate is for
the protocols required to be submitted
with each sample. The collection of
samples is not a collection of
information under 5 CFR 1320.3(h)(2).
Respondents to the collection of
information under § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 69
manufacturers submitted samples and
protocols in fiscal year (FY) 2008, under
the regulations cited previously in this
document. FDA estimates that
approximately 65 manufacturers
submitted protocols under § 610.2 and
21 CFR 610.3 manufacturers submitted
protocols under the regulations
(§§ 660.6 and 660.46) for the other
specific products. FDA received no
submissions under § 660.36; however,
FDA is using the estimate of one
protocol submission in the event one is
submitted in the future.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2008, which totaled
6,314, for the various submission
requirements of samples and protocols
for the licensed biological products. The
rate of final actions is not expected to
change significantly in the next few
years. The hours per response are based
on information provided by industry.
The burden estimates provided by
industry ranged from 1 to 5.5 hours.
Under § 610.2, the hours per response
are based on the average of these
estimates and rounded to 3 hours.
Under the remaining regulations, the
hours per response are based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the other protocols than under § 610.2.
In the Federal Register of March 6,
2009 (74 FR 9820), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
610.2
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
65
95.5
6,208
3
18,624
660.6(b)
2
44
88
5
440
660.36(a)(2) and (b)
1
1
1
6
6
660.46(b)
1
17
17
5
85
Total
69
1 There
Dated: July 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–17978 Filed 7–28–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2009–E–0072]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAPAFLO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
6,314
19,155
are no capital costs or operating and maintenance costs associated with this collection of information.
Notice.
VerDate Nov<24>2008
18:30 Jul 28, 2009
Jkt 217001
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RAPAFLO and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Notices]
[Pages 37714-37715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17978]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0097]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Request for Samples
and Protocols
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
28, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0206.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
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.
Request for Samples and Protocols--(OMB Control Number 0910-0206)--
Extension
Under section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to issue regulations that prescribe
standards designed to ensure the safety, purity, and potency of
biological products and to ensure that the biologics licenses for such
products are only issued when a product meets the prescribed standards.
Under Sec. 610.2 (21 CFR 610.2), the Center for Biologics Evaluation
and Research (CBER) or the Center for Drug Evaluation and Research may
at any time require manufacturers of licensed biological products to
submit to FDA samples of any lot along with the protocols showing the
results of applicable tests prior to distributing the lot of the
product. In addition to Sec. 610.2, there are other regulations that
require the submission of samples and protocols for specific licensed
biological products: Sec. Sec. 660.6 (21 CFR 660.6) (Antibody to
Hepatitis B Surface Antigen); 660.36 (21 CFR 660.36) (Reagent Red Blood
Cells); and 660.46 (21 CFR 660.46) (Hepatitis B Surface Antigen).
Section 660.6(a) provides requirements for the frequency of submission
of samples from each lot of Antibody to Hepatitis B Surface Antigen
product, and Sec. 660.6(b) provides the requirements for the
submission of a protocol containing specific information along with
each required sample. For Sec. 660.6 products subject to official
release by FDA, one sample from each filling of each lot is required to
be submitted along with a protocol consisting of a summary of the
history of manufacture of the product, including all results of each
test for which test results are requested by CBER. After official
release is no longer required, one sample along with a protocol is
required to be submitted at 90-day intervals. In addition, samples,
which must be accompanied by a protocol, may at any time be required to
be submitted to CBER if continued evaluation is deemed necessary.
Section 660.36(a) requires, after each routine establishment
inspection by FDA, the submission of samples from a lot of final
Reagent Red Blood Cell product along with a protocol containing
specific information. Section 660.36(a)(2) requires that a protocol
contain information including, but not limited to, manufacturing
records, certain test records, and identity test results. Section
660.36(b) requires a copy of the antigenic constitution matrix
specifying the antigens present or absent to be submitted to the CBER
Director at the time of initial distribution of each lot. Section
660.46(a) contains requirements as to the frequency of submission of
samples from each lot of Hepatitis B Surface Antigen product, and Sec.
660.46(b) contains the requirements as to the submission of a protocol
containing specific information along with each required sample. For
Sec. 660.46 products subject to official release by FDA, one sample
from each filling of each lot is required to be submitted along with a
protocol consisting of a summary of the history of manufacture of the
product, including all results of each test for which test results are
requested by CBER. After notification of official release is received,
one sample along
[[Page 37715]]
with a protocol is required to be submitted at 90-day intervals. In
addition, samples, which must be accompanied by a protocol, may at any
time be required to be submitted to CBER if continued evaluation is
deemed necessary.
Samples and protocols are required by FDA to help ensure the
safety, purity, or potency of a product because of the potential lot-
to-lot variability of a product produced from living organisms. In
cases of certain biological products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological products) that are known to have
lot-to-lot consistency, official lot release is not normally required.
However, submissions of samples and protocols of these products may
still be required for surveillance, licensing, and export purposes, or
in the event that FDA obtains information that the manufacturing
process may not result in consistent quality of the product.
The following burden estimate is for the protocols required to be
submitted with each sample. The collection of samples is not a
collection of information under 5 CFR 1320.3(h)(2). Respondents to the
collection of information under Sec. 610.2 are manufacturers of
licensed biological products. Respondents to the collection of
information under Sec. Sec. 660.6(b), 660.36(a)(2) and (b), and
660.46(b) are manufacturers of the specific products referenced
previously in this document. The estimated number of respondents for
each regulation is based on the annual number of manufacturers that
submitted samples and protocols for biological products including
submissions for lot release, surveillance, licensing, or export. Based
on information obtained from FDA's database system, approximately 69
manufacturers submitted samples and protocols in fiscal year (FY) 2008,
under the regulations cited previously in this document. FDA estimates
that approximately 65 manufacturers submitted protocols under Sec.
610.2 and 21 CFR 610.3 manufacturers submitted protocols under the
regulations (Sec. Sec. 660.6 and 660.46) for the other specific
products. FDA received no submissions under Sec. 660.36; however, FDA
is using the estimate of one protocol submission in the event one is
submitted in the future.
The estimated total annual responses are based on FDA's final
actions completed in FY 2008, which totaled 6,314, for the various
submission requirements of samples and protocols for the licensed
biological products. The rate of final actions is not expected to
change significantly in the next few years. The hours per response are
based on information provided by industry. The burden estimates
provided by industry ranged from 1 to 5.5 hours. Under Sec. 610.2, the
hours per response are based on the average of these estimates and
rounded to 3 hours. Under the remaining regulations, the hours per
response are based on the higher end of the estimate (rounded to 5 or 6
hours) since more information is generally required to be submitted in
the other protocols than under Sec. 610.2.
In the Federal Register of March 6, 2009 (74 FR 9820), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
610.2 65 95.5 6,208 3 18,624
----------------------------------------------------------------------------------------------------------------
660.6(b) 2 44 88 5 440
----------------------------------------------------------------------------------------------------------------
660.36(a)(2) and 1 1 1 6 6
(b)
----------------------------------------------------------------------------------------------------------------
660.46(b) 1 17 17 5 85
----------------------------------------------------------------------------------------------------------------
Total 69 ................. 6,314 ................. 19,155
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: July 22, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17978 Filed 7-28-09; 8:45 am]
BILLING CODE 4160-01-S
