Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements, 28854-28856 [2013-11631]
Download as PDF
<![CDATA[
28854
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
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.
Postmarket Surveillance—21 CFR Part
822 (OMB Control Number 0910–
0449)—Extension
Section 522 of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 360l)
authorizes the FDA to require a
manufacturers to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides instructions to manufacturers
so they know what information is
required in a PS plan submission. FDA
reviews PS plan submissions in
accordance with part 822 (21 CFR part
822) in §§ 822.15 through 822.19 of the
regulation, which describe the grounds
for approving or disapproving a PS plan.
In addition, the PS regulation provides
instructions to manufacturers to submit
interim and final reports in accordance
with § 822.38. Respondents to this
collection of information are those
manufacturers who require postmarket
surveillance of their products.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Postmarket surveillance submission (§§ 822.9 and 822.10)
Changes to PS plan after approval (§ 822.21) ....................
Changes to PS plan for a device that is no longer marketed (§ 822.28) ................................................................
Waiver (§ 822.29) .................................................................
Exemption request (§ 822.30) ..............................................
Periodic reports (§ 822.38) ...................................................
131
15
1
1
131
15
120
40
15,720
600
80
1
16
131
1
1
1
3
80
1
16
393
8
40
40
40
640
40
640
15,720
Total ..............................................................................
........................
........................
........................
........................
33,360
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Reporting Burden
Estimate: The burden captured in table
1 of this document is based on the data
available in FDA’s internal tracking
system. Sections 822.26, 822.27, and
822.34 do not constitute information
collection subject to review under the
PRA because it entails ‘‘no burden other
than that necessary to identify the
respondent, the date, the respondent’s
address, and the nature of the
instrument’’ (5 CFR 1320.3(h)(1)).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR section
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Manufacturer records (§ 822.31) ..........................................
Investigator records (§ 822.32) ............................................
131
393
1
1
131
393
20
5
2,620
1,965
Total ..............................................................................
........................
........................
........................
........................
4,585
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Explanation of Recordkeeping Burden
Estimate: FDA expects that at least some
of the manufacturers will be able to
satisfy the PS requirement using
information or data they already have.
For purposes of calculating burden,
however, FDA has assumed that each PS
order can only be satisfied by a 3-year
clinically-based surveillance plan, using
three investigators. These estimates are
based on FDA’s knowledge and
experience with postmarket
surveillance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
ACTION:
[FR Doc. 2013–11697 Filed 5–15–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
Food and Drug Administration
[Docket No. FDA–2013–N–0545]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
certain information. 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 invites comments on
the information collection provisions of
our infant formula regulations,
including infant formula labeling,
quality control procedures, notification
requirements, and recordkeeping.
Submit either electronic or
written comments on the collection of
information by July 15, 2013.
DATES:
E:\FR\FM\16MYN1.SGM
16MYN1
28855
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
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:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
ADDRESSES:
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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
SUPPLEMENTARY INFORMATION:
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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 FD&C 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 FD&C
Act (21 U.S.C. 350a) requires
manufacturers of infant formula to
establish and adhere to quality control
procedures, notify us when a batch of
infant formula that has left the
manufacturers’ control may be
adulterated or misbranded, and keep
records of distribution. We have issued
regulations to implement the FD&C
Act’s requirements for infant formula in
parts 106 and 107. We also regulate the
labeling of infant formula under the
authority of section 403 of the FD&C Act
(21 U.S.C. 343). Under our 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), we proposed
changes in our 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 Federal Register of
April 28, 2003 (68 FR 22341) (the 2003
reopening), FDA reopened the comment
period for the proposed rule. Interested
persons were originally given until June
27, 2003, to comment on these issues
and the 1996 proposal. However, in
response to a request, the comment
period was extended to August 26, 2003
(68 FR 38247, June 27, 2003). FDA again
reopened the comment period on
August 1, 2006 (71 FR 43392) (the 2006
reopening) for 45 days to accept
comment on a limited set of issues. In
a notice of proposed rulemaking
published in the Federal Register of
April 16, 2013 (78 FR 22442), we
proposed to amend our regulations on
nutrient specifications and labeling for
infant formula to add the mineral
selenium to the list of required nutrients
and to establish minimum and
maximum levels of selenium in infant
formula. The document also included
revised burden estimates for the
proposed changes and solicited public
comment. In the interim, FDA is seeking
an extension of OMB approval for the
current regulations so that we can
continue to collect information while
the proposals are pending.
We estimate 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 section
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Section 412(d) of the FD&C Act ..........................................
§ 106.120(b) .........................................................................
§ 107.50(b)(3) and (b)(4) ......................................................
§ 107.50(e)(2) .......................................................................
5
1
3
1
13
1
2
1
65
1
6
1
10
4
4
4
650
4
24
4
Total ..............................................................................
........................
........................
........................
........................
682
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
tkelley on DSK3SPTVN1PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
§ 106.100 ..............................................................................
§ 107.50(c)(3) .......................................................................
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
PO 00000
Frm 00060
Number of
records per
recordkeeper
5
3
Fmt 4703
Sfmt 4703
Total annual
records
10
10
E:\FR\FM\16MYN1.SGM
Average
burden per
recordkeeping
50
30
16MYN1
400
300
Total hours
20,000
9,000
28856
Federal Register / Vol. 78, No. 95 / Thursday, May 16, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Total ..............................................................................
1 There
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
21 CFR Section
........................
........................
........................
Total hours
29,000
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
§§ 107.10(a) and 107.20 ......................................................
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
Number of
disclosures
per
respondent
Number of
respondents
21 CFR Section
5
Total annual
disclosures
13
65
Average
burden per
disclosure
Total hours
8
520
are no capital costs or operating and maintenance costs associated with this collection of information.
In compiling these estimates, we
consulted our records of the number of
infant formula submissions received in
the past. All infant formula submissions
may be provided to us in electronic
format. The hours per response
reporting estimates are based on our
experience with similar programs and
information received from industry.
We estimate that we will receive 13
reports from 5 manufacturers annually
under section 412(d) of the FD&C 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. We
also estimate that we 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, we
estimate that we 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. We
also estimate that we will receive one
notification annually under
§ 107.50(e)(2) and that the notification
will take 4 hours to prepare.
We estimate that 5 firms will expend
approximately 20,000 hours per year to
fully satisfy the recordkeeping
requirements in § 106.100 and that 3
firms will expend approximately 9,000
hours per year to fully satisfy the
recordkeeping requirements in
§ 107.50(c)(3).
We estimate compliance with our
labeling requirements in §§ 107.10(a)
and 107.20 requires 520 hours annually
by 5 manufacturers.
Dated: May 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–11631 Filed 5–15–13; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:13 May 15, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Bar Code Label Requirement for
Human Drug and Biological Products—
(OMB Control Number 0910–0537)—
Extension
[Docket No. FDA–2012–N–0873]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Bar Code Label
Requirement for Human Drug and
Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 17,
2013.
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0537. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
In the Federal Register of February
26, 2004 (69 FR 9120), we issued
regulations that required human drug
product and biological product labels to
have bar codes. The rule required bar
codes on most human prescription drug
products and on over-the-counter (OTC)
drug products that are dispensed under
an order and commonly used in health
care facilities. The rule also required
machine-readable information on blood
and blood components. For human
prescription drug products and OTC
drug products that are dispensed under
an order and commonly used in health
care facilities, the bar code must contain
the National Drug Code number for the
product. For blood and blood
components, the rule specifies the
minimum contents of the machinereadable information in a format
approved by the Center for Biologics
Evaluation and Research Director as
blood centers have generally agreed
upon the information to be encoded on
the label. The rule is intended to help
reduce the number of medication errors
in hospitals and other health care
settings by allowing health care
professionals to use bar code scanning
equipment to verify that the right drug
(in the right dose and right route of
administration) is being given to the
right patient at the right time.
Most of the information collection
burden resulting from the final rule, as
calculated in table 1 of the final rule (69
FR 9120 at 9149), was a one-time
burden that does not occur after the
rule’s compliance date of April 26,
2006. In addition, some of the
information collection burden estimated
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28854-28856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11631]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0545]
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 or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. 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
invites comments on the information collection provisions of our infant
formula regulations, including infant formula labeling, quality control
procedures, notification requirements, and recordkeeping.
DATES: Submit either electronic or written comments on the collection
of information by July 15, 2013.
[[Page 28855]]
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 FD&C 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 FD&C Act (21
U.S.C. 350a) requires manufacturers of infant formula to establish and
adhere to quality control procedures, notify us when a batch of infant
formula that has left the manufacturers' control may be adulterated or
misbranded, and keep records of distribution. We have issued
regulations to implement the FD&C Act's requirements for infant formula
in parts 106 and 107. We also regulate the labeling of infant formula
under the authority of section 403 of the FD&C Act (21 U.S.C. 343).
Under our 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), we proposed changes in our
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
Federal Register of April 28, 2003 (68 FR 22341) (the 2003 reopening),
FDA reopened the comment period for the proposed rule. Interested
persons were originally given until June 27, 2003, to comment on these
issues and the 1996 proposal. However, in response to a request, the
comment period was extended to August 26, 2003 (68 FR 38247, June 27,
2003). FDA again reopened the comment period on August 1, 2006 (71 FR
43392) (the 2006 reopening) for 45 days to accept comment on a limited
set of issues. In a notice of proposed rulemaking published in the
Federal Register of April 16, 2013 (78 FR 22442), we proposed to amend
our regulations on nutrient specifications and labeling for infant
formula to add the mineral selenium to the list of required nutrients
and to establish minimum and maximum levels of selenium in infant
formula. The document also included revised burden estimates for the
proposed changes and solicited public comment. In the interim, FDA is
seeking an extension of OMB approval for the current regulations so
that we can continue to collect information while the proposals are
pending.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Federal food, drug, and cosmetic Number of responses per Total annual Average burden Total hours
act or 21 CFR section respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Section 412(d) of the FD&C Act.. 5 13 65 10 650
Sec. 106.120(b)............... 1 1 1 4 4
Sec. 107.50(b)(3) and (b)(4).. 3 2 6 4 24
Sec. 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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec. 106.100.................. 5 10 50 400 20,000
Sec. 107.50(c)(3)............. 3 10 30 300 9,000
-------------------------------------------------------------------------------
[[Page 28856]]
Total....................... .............. .............. .............. .............. 29,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Sec. Sec. 107.10(a) and 5 13 65 8 520
107.20.........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In compiling these estimates, we consulted our records of the
number of infant formula submissions received in the past. All infant
formula submissions may be provided to us in electronic format. The
hours per response reporting estimates are based on our experience with
similar programs and information received from industry.
We estimate that we will receive 13 reports from 5 manufacturers
annually under section 412(d) of the FD&C 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. We also estimate that we 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, we estimate that we will receive two
reports from three manufacturers annually under Sec. 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. We also
estimate that we will receive one notification annually under Sec.
107.50(e)(2) and that the notification will take 4 hours to prepare.
We estimate that 5 firms will expend approximately 20,000 hours per
year to fully satisfy the recordkeeping requirements in Sec. 106.100
and that 3 firms will expend approximately 9,000 hours per year to
fully satisfy the recordkeeping requirements in Sec. 107.50(c)(3).
We estimate compliance with our labeling requirements in Sec. Sec.
107.10(a) and 107.20 requires 520 hours annually by 5 manufacturers.
Dated: May 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11631 Filed 5-15-13; 8:45 am]
BILLING CODE 4160-01-P
