Agency Information Collection Activities; Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs, 20677-20679 [2011-8820]
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
multiple claims and other labeling
statements on food packages may affect
how consumers perceive a product or a
label, which may in turn affect their
dietary choices. Results of the study will
not be used to develop population
estimates.
To help design and refine the
questionnaire, FDA plans to conduct
cognitive interviews by screening 72
panelists in order to obtain 9
participants in the interviews. Each
screening is expected to take 5 minutes
(0.083 hour) and each cognitive
interview is expected to take 1 hour.
The total for cognitive interview
activities is 15 hours (6 hours + 9
hours). Subsequently, we plan to
conduct pretests of the questionnaire
before it is administered in the study.
We expect that 1,600 invitations, each
taking 2 minutes (0.033 hour), will need
to be sent to panelists to have 200 of
them complete a 15-minute (0.25 hour)
pretest. The total for the pretest
activities is 106 hours (53 hours + 50
hours). For the survey, we estimate that
32,000 invitations, each taking 2
minutes (0.033 hour) to complete, will
need to be sent to the consumer panel
to have 3,000 of its members complete
a 15-minute (0.25 hour) questionnaire.
The total for the survey activities is
2,056 hours (1,056 hours + 1,000 hours).
Thus, the total estimated burden is
2,174 hours. FDA’s burden estimate is
based on prior experience with research
that is similar to this proposed study.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Cognitive interview screener ................................................
Cognitive interview ...............................................................
Pretest invitation ..................................................................
Pretest ..................................................................................
Survey invitation ...................................................................
Survey ..................................................................................
72
9
1,600
200
32,000
4,000
1
1
1
1
1
1
72
9
1,600
200
32,000
4,000
5/60
1
2/60
15/60
2/60
15/60
6
9
53
50
1,056
1,000
Total ..............................................................................
........................
........................
........................
........................
2,174
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
II. References
mstockstill on DSKH9S0YB1PROD with NOTICES
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but we are not
responsible for any subsequent changes
to the Web site after this document
publishes in the Federal Register.)
1. U.S. Food and Drug Administration.
Claims That Can Be Made for
Conventional Foods and Dietary
Supplements. September 2003. Available
at https://www.fda.gov/Food/
LabelingNutrition/LabelClaims/
ucm111447.htm.
2. Kellogg’s. Nutrition at a Glance. 2010.
Available at https://
www.kelloggnutrition.com/learn-aboutlabels/nutrition-at-a-glance.html.
3. PepsiCo. Nutrition Labeling. 2010.
Available at https://www.pepsico.com/
Purpose/Human-Sustainability/
Nutrition-Labeling.html.
4. Schmit, J. ‘‘PepsiCo Labels Some of Its
Products ‘Smart,’’’ USA Today,
September 2, 2004. Available at https://
www.usatoday.com/money/industries/
food/2004–09–02-smart-spot_x.htm.
5. Kraft Foods. Sensible Solution. 2010.
Available at https://
www.kraftrecipes.com/kf/HealthyLiving/
SensibleSolution/
SensibleSolution_Landing.aspx.
6. Centers for Disease Control and
Prevention. 2005–2006 National Health
and Examination Survey questionnaire,
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
Diet Behavior and Nutrition section.
Unpublished results of questions
DBQ.750 and DBQ.780. Questionnaire is
available at https://www.cdc.gov/nchs/
data/nhanes/nhanes_05_06/
sp_dbq_d.pdf.
7. U.S. Food and Drug Administration. 2008
Health and Diet Survey. March 20, 2010.
Available at https://www.fda.gov/Food/
ScienceResearch/ResearchAreas/
ConsumerResearch/ucm193895.htm.
8. Food Marketing Institute. 2009 U.S.
Grocery Shopper Trends Survey.
Washington, DC 2009.
9. Drichoutis, A.C., Lazaridis, P. and Nayga,
R.M., ‘‘Consumers’ Use of Nutritional
Labels: a Review of Research Studies and
Issues,’’ Academy of Marketing Science
Review, 2006(9), 2006. Available at
https://www.amsreview.org/articles/
drichoutis09-2006.pdf.
¨
¨
10. Lahteenmaki, L., Lampila, P.. Grunert, K.,
˚
¨
Boztug, Y., Ueland, ;., Astrom, A. and
´
Martinsdottir, E., ‘‘Impact of HealthRelated Claims on the Perception of
Other Product Attributes,’’ Food Policy,
23: 230–9. 2010.
11. Labiner-Wolfe, J., Lin, C.-T. J. and Verrill
L., ‘‘Effect of Low Carbohydrate Claims
on Consumer Perceptions about Food
Products’ Healthfulness and Helpfulness
for Weight Management,’’ Journal of
Nutrition Education and Behavior, 42(5):
315–320, 2010.
12. Roe, B., Levy, A.S., and Derby, B.M., ‘‘The
Impact of Health Claims on Consumer
Search and Product Evaluation
Outcomes: Evidence from FDA
Experimental Data,’’ Journal of Public
Policy and Marketing, 18(1): 89–105,
1999.
13. LeGault, L., Brandt, M.B., McCabe, N.,
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Adler, C., Brown, A.-M., and Brecher, S.,
‘‘2000–2001 Food Label and Package
Survey: An Update on Prevalence of
Nutrition Labeling and Claims on
Processed, Packaged Foods,’’ Journal of
the American Dietetic Association,
104(6): 952–8, 2004.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8908 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0237]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug;
Postmarketing Reports; Reporting
Information About Authorized Generic
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
E:\FR\FM\13APN1.SGM
13APN1
20678
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
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
public comment in response to the
notice. This notice solicits comments on
the requirements for a New Drug
Application (NDA) holder to notify the
Agency if an authorized generic drug is
marketed by clearly including this
information in an easily accessible place
in the annual report and by sending a
copy of the relevant portion of the
annual report to a central contact point
in the Agency.
DATES: Submit either electronic or
written comments on the collection of
information by June 13, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit 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 OMB control number
0910–0646. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3792, Elizabeth.Berbakos@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
Applications for Food and Drug
Administration Approval To Market a
New Drug; Postmarketing Reports;
Reporting Information About
Authorized Generic Drugs—21 CFR
314.81(b)(2)—(OMB Control Number
0910–0646—Extension)
In the Federal Register of July 28,
2009 (74 FR 37163), FDA published a
final rule that required the holder of an
NDA to notify the Agency if an
authorized generic drug is marketed by
clearly including this information in
annual reports in an easily accessible
place and by sending a copy of the
relevant portion of the annual reports to
a central contact point. We took this
action as part of our implementation of
the Food and Drug Administration
Amendments Act, which requires that
FDA publish a list of all authorized
generic drugs included in an annual
report after January 1, 1999, and that the
Agency update the list quarterly. We
initially published this list on June 27,
2008, on the Internet and notified
relevant Federal Agencies that the list
was published, and we will continue to
update it.
During the past several years, FDA
has been reviewing annual reports it has
received under § 314.81(b)(2) (21 CFR
314.81(b)(2)) to discern whether an
authorized generic drug is being
marketed by the NDA holder. Based on
information learned from this review
and based on the number of annual
reports the Agency currently receives
under § 314.81(b)(2), we estimate that
we will receive approximately 400
annual reports containing the
information required under
§ 314.81(b)(2)(ii)(b), for authorized
generic drugs that were marketed during
the time period covered by an annual
report submitted after January 1, 1999.
Based on the number of sponsors that
currently submit annual reports, we
estimate that approximately 60 sponsors
will submit these 400 annual reports
with authorized generics. As indicated
in table 1 of this document, we are
estimating that the same number of
annual reports will be submitted each
year from the same number of sponsors
containing the information required
under § 314.81(b)(2)(ii)(b), and that the
same number of copies of that portion
of each annual report containing the
authorized generic drug information
will be submitted from the same number
of sponsors. Concerning the hours per
response, based on our estimate of 40
hours to prepare each annual report
currently submitted under
§ 314.81(b)(2), we estimate that sponsors
will need approximately 1 hour to
prepare the information required under
§ 314.81(b)(2)(ii)(b) for each authorized
generic drug that was marketed during
the time period covered by an annual
report submitted after January 1, 1999;
approximately 15 minutes to prepare
the information required under
§ 314.81(b)(2)(ii)(b) for each subsequent
annual report; and approximately 3
minutes to submit to FDA a copy of that
portion of each annual report containing
the authorized generic drug information.
FDA estimates the burden of this
collection of information as follows:
mstockstill on DSKH9S0YB1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR 314.81(b)(2)(ii)(b)
Authorized generic drug information on first marketed
generics in an annual report under § 314.81(b)(2)(ii)(b) ..
Authorized generic drug information submitted in each
subsequent annual report ................................................
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
PO 00000
Frm 00056
Number of
reponses per
respondent
Total annual
respondents
Average
burden per
response
(in hours)
Total hours
60
400
1
400
60
Fmt 4703
6.7
6.7
400
15/60
100
Sfmt 4703
E:\FR\FM\13APN1.SGM
13APN1
20679
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR 314.81(b)(2)(ii)(b)
Number of
reponses per
respondent
Total annual
respondents
Average
burden per
response
(in hours)
Total hours
The submission of a copy of that portion of each annual
report containing authorized generic drug information ....
60
6.7
400
3/60
20
Total ..............................................................................
........................
........................
........................
........................
520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8820 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0157]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application Review
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
public comment in response to the
notice. This notice solicits comments on
the proposed collection of information
concerning requests by sponsors of
investigational new drugs and
applicants for new drug approvals or
biologics licenses for fast track
designation as provided in the guidance
for industry on fast track drug
development programs.
DATES: Submit either electronic or
written comments on the collection of
information by June 13, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
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, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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,
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
when appropriate, and other forms of
information technology.
Guidance for Industry: Fast Track Drug
Development Programs: Designation,
Development, and Application
Review—(OMB Control Number 0910–
0389)—Extension
Section 112(a) of the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115)
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding
section 506 (21 U.S.C. 356). The section
authorizes FDA to take appropriate
action to facilitate the development and
expedite the review of new drugs,
including biological products, intended
to treat a serious or life-threatening
condition and that demonstrate a
potential to address an unmet medical
need. Under section 112(b) of FDAMA,
FDA issued guidance to industry on fast
track policies and procedures outlined
in section 506 of the FD&C Act. The
guidance discusses collections of
information that are specified under
section 506 of the FD&C Act, other
sections of the Public Health Service
Act (the PHS Act), or implementing
regulations. The guidance describes
three general areas involving collection
of information: (1) Fast track
designation requests; (2) premeeting
packages; and (3) requests to submit
portions of an application. Of these, fast
track designation requests and
premeeting packages, in support of
receiving a fast track program benefit,
provide for additional collections of
information not covered elsewhere in
statute or regulation. Information in
support of fast track designation or fast
track program benefits that has
previously been submitted to the
Agency, may, in some cases, be
incorporated into the request by
referring to the information rather than
resubmitting it.
Under section 506(a)(1) of the FD&C
Act, an applicant who seeks fast track
designation is required to submit a
request to the Agency showing that the
product: (1) Is intended for a serious or
life-threatening condition and (2) has
the potential to address an unmet
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20677-20679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8820]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0237]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Applications for Food and Drug Administration Approval
To Market a New Drug; Postmarketing Reports; Reporting Information
About Authorized Generic Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
[[Page 20678]]
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
public comment in response to the notice. This notice solicits comments
on the requirements for a New Drug Application (NDA) holder to notify
the Agency if an authorized generic drug is marketed by clearly
including this information in an easily accessible place in the annual
report and by sending a copy of the relevant portion of the annual
report to a central contact point in the Agency.
DATES: Submit either electronic or written comments on the collection
of information by June 13, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit 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 OMB control number 0910-0646.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3792, Elizabeth.Berbakos@
fda.hhs.gov.
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.
Applications for Food and Drug Administration Approval To Market a New
Drug; Postmarketing Reports; Reporting Information About Authorized
Generic Drugs--21 CFR 314.81(b)(2)--(OMB Control Number 0910-0646--
Extension)
In the Federal Register of July 28, 2009 (74 FR 37163), FDA
published a final rule that required the holder of an NDA to notify the
Agency if an authorized generic drug is marketed by clearly including
this information in annual reports in an easily accessible place and by
sending a copy of the relevant portion of the annual reports to a
central contact point. We took this action as part of our
implementation of the Food and Drug Administration Amendments Act,
which requires that FDA publish a list of all authorized generic drugs
included in an annual report after January 1, 1999, and that the Agency
update the list quarterly. We initially published this list on June 27,
2008, on the Internet and notified relevant Federal Agencies that the
list was published, and we will continue to update it.
During the past several years, FDA has been reviewing annual
reports it has received under Sec. 314.81(b)(2) (21 CFR 314.81(b)(2))
to discern whether an authorized generic drug is being marketed by the
NDA holder. Based on information learned from this review and based on
the number of annual reports the Agency currently receives under Sec.
314.81(b)(2), we estimate that we will receive approximately 400 annual
reports containing the information required under Sec.
314.81(b)(2)(ii)(b), for authorized generic drugs that were marketed
during the time period covered by an annual report submitted after
January 1, 1999. Based on the number of sponsors that currently submit
annual reports, we estimate that approximately 60 sponsors will submit
these 400 annual reports with authorized generics. As indicated in
table 1 of this document, we are estimating that the same number of
annual reports will be submitted each year from the same number of
sponsors containing the information required under Sec.
314.81(b)(2)(ii)(b), and that the same number of copies of that portion
of each annual report containing the authorized generic drug
information will be submitted from the same number of sponsors.
Concerning the hours per response, based on our estimate of 40 hours to
prepare each annual report currently submitted under Sec.
314.81(b)(2), we estimate that sponsors will need approximately 1 hour
to prepare the information required under Sec. 314.81(b)(2)(ii)(b) for
each authorized generic drug that was marketed during the time period
covered by an annual report submitted after January 1, 1999;
approximately 15 minutes to prepare the information required under
Sec. 314.81(b)(2)(ii)(b) for each subsequent annual report; and
approximately 3 minutes to submit to FDA a copy of that portion of each
annual report containing the authorized generic drug information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR 314.81(b)(2)(ii)(b) respondents reponses per respondents response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Authorized generic drug 60 6.7 400 1 400
information on first marketed
generics in an annual report
under Sec.
314.81(b)(2)(ii)(b)............
Authorized generic drug 60 6.7 400 15/60 100
information submitted in each
subsequent annual report.......
[[Page 20679]]
The submission of a copy of that 60 6.7 400 3/60 20
portion of each annual report
containing authorized generic
drug information...............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 520
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8820 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P
