Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements, 23777-23779 [2010-10360]
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Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices
FORMAT
Order
Drug Facts
Minimal Column
Column Plus
Warning first
Indication first
The Order manipulation will vary the
primacy of the boxed warning
information versus the paragraph about
the uses to the drug. In terms of Format,
the Drug Facts format will follow the
conventions of the existing OTC
labeling. The Minimal Column
condition will contain information in
two columns with only basic
information in the sections regarding
information patients should tell their
doctors. The Column Plus condition
will also present information in two
columns, but will include additional
contextual information in the sections
about what information patients should
report to their doctors.
Participants with relevant medical
conditions will be randomly assigned to
one of the six experimental conditions
and each participant will see only one
version of the patient information.
Participants will be prescreened to
represent a range of health literacy
levels, including a portion with low
literacy. Thus, all participants in the
study will have been diagnosed with
rheumatoid arthritis, ankylosing
spondylitis, or plaque psoriasis and at
are being effectively met. Research
related to the functionality and
effectiveness of written patient
information consistently identifies the
importance of performance-based
testing as well as content based testing,
which enables the evaluation of
materials in order to assure their utility
and identify issues in content format, or
design. Development of new
prescription drug patient materials must
be based on consumer testing that
focuses on utility to the patient and
comprehension of material in the
broadest audience possible. FDA has
developed three prototypes in order to
user test prescription drug information
with consumers in order to achieve this
goal. For further information, contact
Elizabeth Berbakos (see FOR FURTHER
INFORMATION CONTACT).
The burden table reflects up to three
pretests of 180 individuals each, 900
participants in the main study, and 200
participants in the followup study
involving electronic administration.
FDA estimates the burden of this
collection of information as follows:
least 30 percent of the sample will fall
in the lower range of literacy. Because
the average reading level in the United
States is estimated to be 8th grade9 and
it is recommended that consumer
medication information be written at a
5th grade reading level,10 the low
literate cohort will consist of consumers
who have 5th to 8th grade reading skills.
Education level is not a reliable
substitute for literacy testing. At
screening, the participants will be
assessed for literacy level using a
validated instrument.
An additional small study will be
conducted via the Internet to determine
whether electronic prototype
presentation alters the processing of the
information in any way. Two-hundred
individuals with the same
characteristics of the original sample
(e.g., medical condition and literacy
levels) will be recruited over the
Internet and will complete the same
questionnaire as original participants.
FDA is undertaking this study
because it does not yet have sufficient
evidence-based research relating to
patient needs, or whether those needs
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
No. of Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
540
1
540
20/60
178
900
1
900
25/60
369
200
1
200
25/60
82
Total
1 There
629
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
HHS.
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
Education Pages in Health-Related Journals,’’
Journal of Community Health, 30(3), 213–219, 2005.
10 Andrus, M.R., M.T. Roth, ‘‘Health Literacy: A
Review,’’ Pharmacotherapy, 22(3), 282–302, 2002.
Food and Drug Administration
[Docket No. FDA–2010–N–0190]
[FR Doc. 2010–10359 Filed 5–3–10; 8:45 am]
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ACTION:
BILLING CODE 4160–01–S
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
9 Cotunga N., C.E. Vickery, K.M. CarpenterHaefele, ‘‘Evaluation of Literacy Level of Patient
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Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection regarding the
manufacture of infant formula,
including infant formula labeling,
quality control procedures, notification
requirements, and recordkeeping.
DATES: Submit written or electronic
comments on the collection of
information by July 6, 2010.
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
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
SUPPLEMENTARY INFORMATION:
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.
Infant Formula Requirements—21 CFR
Parts 106 and 107 (OMB Control
Number 0910–0256)—Extension
Statutory requirements for infant
formula under the Federal Food, Drug,
and Cosmetic Act (the act) are intended
to protect the health of infants and
include a number of reporting and
recordkeeping requirements. Among
other things, section 412 of the act (21
U.S.C. 350a) requires manufacturers of
infant formula to establish and adhere to
quality control procedures, notify FDA
when a batch of infant formula that has
left the manufacturers’ control may be
adulterated or misbranded, and keep
records of distribution. FDA has issued
regulations to implement the act’s
requirements for infant formula in parts
106 and 107 (21 CFR parts 106 and 107).
FDA also regulates the labeling of infant
formula under the authority of section
403 of the act (21 U.S.C. 343). Under the
labeling regulations for infant formula
in part 107, the label of an infant
formula must include nutrient
information and directions for use. The
purpose of these labeling requirements
is to ensure that consumers have the
information they need to prepare and
use infant formula appropriately. In a
notice of proposed rulemaking
published in the Federal Register of
July 9, 1996 (61 FR 36154), FDA
proposed changes in the infant formula
regulations, including some of those
listed in tables 1, 2, and 3 of this
document. The document included
revised burden estimates for the
proposed changes and solicited public
comment. In the interim, however, FDA
is seeking an extension of OMB
approval for the current regulations so
that it can continue to collect
information while the proposal is
pending.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Federal Food, Drug, and Cosmetic Act or 21 CFR Section
Annual Frequency
per
Response
No. of
Respondents
Total Annual
Responses
Hours per
Response
Total Hours
Section 412(d) of the act
5
13
65
10
650
21 CFR 106.120(b)
1
1
1
4
4
21 CFR 107.50(b)(3) and (b)(4)
3
2
6
4
24
21 CFR 107.50(e)(2)
1
1
1
4
4
Total
1 There
682
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR
Section
Annual Frequency
per
Recordkeeping
No. of
Recordkeepers
Total Annual
Records
Hours per
Record
Total Hours
106.100
5
10
50
400
20,000
107.50 (c)(3)
3
10
30
300
9,000
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Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued
21 CFR
Section
Annual Frequency
per
Recordkeeping
No. of
Recordkeepers
Total Annual
Records
Hours per
Record
Total Hours
Total
29,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3.—THIRD PARTY DISCLOSURE REQUIREMENTS1
21 CFR Section
No. of
Respondents
21 CFR 107.10(a) and 107.20
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1 There
Annual Frequency
of Disclosure
5
Total Annual
Disclosures
13
Hours per
Disclosure
65
Total Hours
8
520
are no capital costs or operating and maintenance costs associated with this collection of information
In compiling these estimates, FDA
consulted its records of the number of
infant formula submissions received in
the past. All infant formula submissions
to FDA may be provided in electronic
format. The hours per response
reporting estimates are based on FDA’s
experience with similar programs and
information received from industry.
FDA estimates that it will receive 13
reports from 5 manufacturers annually
under section 412(d) of the act, for a
total annual response of 65 reports. Each
report is estimated to take 10 hours per
response for a total of 650 hours. FDA
also estimates that it will receive one
notification under § 106.120(b). The
notification is expected to take 4 hours
per response, for a total of 4 hours.
For exempt infant formula, FDA
estimates that it will receive two reports
from three manufacturers annually
under § 107.50(b)(3) and (b)(4), for a
total annual response of six reports.
Each report is estimated to take 4 hours
per response for a total of 24 hours. FDA
also estimates that it will receive one
notification under § 107.50(e)(2). The
notification is expected to take 4 hours
per response, for a total of 4 hours.
FDA estimates that 5 firms will
expend approximately 20,000 hours per
year to fully satisfy the record keeping
requirements in § 106.100. It is
estimated that 3 firms will expend
approximately 9,000 hours per year to
fully satisfy the record keeping
requirements in § 107.50(c)(3).
FDA estimates that compliance with
the labeling requirements of §§ 107.10(a)
and 107.20 will require 520 hours
annually by 5 manufacturers.
Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–10360 Filed 5–3–10; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0507]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format
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 June 3,
2010.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0530. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
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has submitted the following proposed
collection of information to OMB for
review and clearance.
Requirements for Submission of
Labeling for Human Prescription Drugs
and Biologics in Electronic Format—
OMB Control Number 0910–0530—
Extension
FDA is requesting that OMB extend
approval under the Paperwork
Reduction Act (44 USC 3501–3520) for
the information collection resulting
from the requirement that the content of
labeling for prescription drug products
be submitted to FDA electronically in a
form that FDA can process, review, and
archive. This requirement was set forth
in the final rule entitled ‘‘Requirements
for Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format’’ (December 11, 2003;
68 FR 69009), which amended FDA
regulations governing the format in
which certain labeling is required to be
submitted for FDA review with new
drug applications (NDAs) (21 CFR
314.50(l)(1)(i)), including supplemental
NDAs, abbreviated new drug
applications (ANDAs) (21 CFR
314.94(d)(1)(ii)), including
supplemental ANDAs, and annual
reports (21 CFR 314.81(b)(2)(iii)(b)) (the
final rule also applied to certain
Biologics License Applications, but the
information collection for these
requirements is not part of this OMB
approval request).
This OMB approval request is only for
the burden associated with the
electronic submission of the content of
labeling. The burden for submitting
labeling as part of NDAs, ANDAs,
supplemental NDAs and ANDAs, and
annual reports, has been approved by
OMB under Control Number 0910–0001.
When we last requested that OMB
extend approval for this information
collection (see the Federal Register of
March 29, 2006 (71 FR 15752)), we
received several comments. Generally,
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[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23777-23779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10360]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0190]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Infant Formula Requirements
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 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
[[Page 23778]]
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
regarding the manufacture of infant formula, including infant formula
labeling, quality control procedures, notification requirements, and
recordkeeping.
DATES: Submit written or electronic comments on the collection of
information by July 6, 2010.
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 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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Infant Formula Requirements--21 CFR Parts 106 and 107 (OMB Control
Number 0910-0256)--Extension
Statutory requirements for infant formula under the Federal Food,
Drug, and Cosmetic Act (the act) are intended to protect the health of
infants and include a number of reporting and recordkeeping
requirements. Among other things, section 412 of the act (21 U.S.C.
350a) requires manufacturers of infant formula to establish and adhere
to quality control procedures, notify FDA when a batch of infant
formula that has left the manufacturers' control may be adulterated or
misbranded, and keep records of distribution. FDA has issued
regulations to implement the act's requirements for infant formula in
parts 106 and 107 (21 CFR parts 106 and 107). FDA also regulates the
labeling of infant formula under the authority of section 403 of the
act (21 U.S.C. 343). Under the labeling regulations for infant formula
in part 107, the label of an infant formula must include nutrient
information and directions for use. The purpose of these labeling
requirements is to ensure that consumers have the information they need
to prepare and use infant formula appropriately. In a notice of
proposed rulemaking published in the Federal Register of July 9, 1996
(61 FR 36154), FDA proposed changes in the infant formula regulations,
including some of those listed in tables 1, 2, and 3 of this document.
The document included revised burden estimates for the proposed changes
and solicited public comment. In the interim, however, FDA is seeking
an extension of OMB approval for the current regulations so that it can
continue to collect information while the proposal is pending.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Federal Food, Drug, and Cosmetic Act or 21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 412(d) of the act 5 13 65 10 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 106.120(b) 1 1 1 4 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(b)(3) and (b)(4) 3 2 6 4 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(e)(2) 1 1 1 4 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 682
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual
Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
106.100 5 10 50 400 20,000
----------------------------------------------------------------------------------------------------------------
107.50 3 10 30 300 9,000
(c)(3)
----------------------------------------------------------------------------------------------------------------
[[Page 23779]]
Total 29,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3.--Third Party Disclosure Requirements\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents of Disclosure Disclosures Disclosure Total Hours
----------------------------------------------------------------------------------------------------------------
21 CFR 5 13 65 8 520
107.10(a)
and 107.20
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information
In compiling these estimates, FDA consulted its records of the
number of infant formula submissions received in the past. All infant
formula submissions to FDA may be provided in electronic format. The
hours per response reporting estimates are based on FDA's experience
with similar programs and information received from industry.
FDA estimates that it will receive 13 reports from 5 manufacturers
annually under section 412(d) of the act, for a total annual response
of 65 reports. Each report is estimated to take 10 hours per response
for a total of 650 hours. FDA also estimates that it will receive one
notification under Sec. 106.120(b). The notification is expected to
take 4 hours per response, for a total of 4 hours.
For exempt infant formula, FDA estimates that it will receive two
reports from three manufacturers annually under Sec. 107.50(b)(3) and
(b)(4), for a total annual response of six reports. Each report is
estimated to take 4 hours per response for a total of 24 hours. FDA
also estimates that it will receive one notification under Sec.
107.50(e)(2). The notification is expected to take 4 hours per
response, for a total of 4 hours.
FDA estimates that 5 firms will expend approximately 20,000 hours
per year to fully satisfy the record keeping requirements in Sec.
106.100. It is estimated that 3 firms will expend approximately 9,000
hours per year to fully satisfy the record keeping requirements in
Sec. 107.50(c)(3).
FDA estimates that compliance with the labeling requirements of
Sec. Sec. 107.10(a) and 107.20 will require 520 hours annually by 5
manufacturers.
Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10360 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S
