Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements, 1539-1540 [E7-331]
Download as PDF
<![CDATA[
1539
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Notices
Food and Drug Administration
[Docket No. 2006N–0528]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Infant Formula
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Infant Formula Requirements—21 CFR
Parts 106 and 107 (OMB Control
Number 0910–0256)—Extension
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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 March 13, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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.
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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.
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 21
CFR part 106 and part 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)
(the 1996 proposed rule), FDA proposed
changes in the infant formula
regulations, including some of those
listed in tables 1 and 2 of this
document. The 1996 proposed rule
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
Section of the Federal Food,
Drug, and Cosmetic Act or 21
CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses2
13
65
5
21 CFR 106.120(b)
5
21 CFR 107.10(a) and 107.20
5
13
21 CFR 107.50(b)(3) and (b)(4)
rmajette on PROD1PC67 with NOTICES
Section 412(d) of the act
3
21 CFR 107.50(e)(2)
3
Hours per
Response
10
650
4
5
65
8
520
2
6
4
24
0.33
1
4
4
0.25
1.25
Total
1There
Total Hours
1,203
are no capital costs or operating and maintenance costs associated with this collection of information.
may submit infant formula notifications in electronic format.
2Manufacturers
VerDate Aug<31>2005
15:41 Jan 11, 2007
Jkt 211001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\12JAN1.SGM
12JAN1
1540
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
106.100
5
10
50
4,000
200,000
107.50(c)(3)
3
10
30
3,000
90,000
Total
290,000
1There
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. The figures for hours per
response are based on estimates from
experienced persons in the agency and
in industry.
Dated: January 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–331 Filed 1–11–07; 8:45 am]
A. Background
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice Regarding 340B Drug Pricing
Program-Contract Pharmacy Services
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
SUMMARY: Section 340B of the Public
Health Service Act implements a drug
pricing program in which manufacturers
who sell covered outpatient drugs to
covered entities must agree to charge a
price that will not exceed an amount
determined under a statutory formula.
The purpose of this notice is to inform
interested parties of proposed
guidelines regarding contract pharmacy
services that will allow covered entities
to utilize contract pharmacy services
arrangements previously limited to the
Alternative Methods Demonstration
Project program.
The public is invited to comment
on the proposed guidelines by March
13, 2007. After consideration of the
submitted comments, the Health
Resources and Services Administration
(HRSA) will issue the final guidelines.
DATES:
Address all comments to
Mr. Bradford R. Lang, Public Health
Analyst, Office of Pharmacy Affairs
(OPA), Health Resources and Services
Administration (HRSA), 5600 Fishers
Lane, Parklawn Building, Room 10C–03,
Rockville, MD 20857.
rmajette on PROD1PC67 with NOTICES
ADDRESSES:
VerDate Aug<31>2005
15:41 Jan 11, 2007
Jkt 211001
Mr.
Jimmy Mitchell, Director, OPA, HRSA,
5600 Fishers Lane, Parklawn Building,
Room 10C–03, Rockville, MD 20857, or
by telephone through the Pharmacy
Services Support Center at 1–800–628–
6297.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act, Limitation on Prices
of Drugs Purchased by Covered Entities.
Previous guidelines pertaining to
contract pharmacy services for the 340B
drug pricing program (61 FR 43549,
Aug. 23, 1996) stated that a covered
entity could contract with only one
pharmacy to provide all pharmacy
services for any particular site of the
covered entity. Furthermore, if the
contract pharmacy had multiple
locations, the covered entity site had to
choose one, and only one, contract
pharmacy location for provision of these
services.
In 2001, HRSA established
Alternative Methods Demonstration
Projects (AMDPs) which allowed
covered entities that applied and were
approved by HRSA to pursue
alternatives to contracting with a single
pharmacy. These alternative models
included the following: (1) The use of
multiple contract pharmacy service
sites, (2) the utilization of a contract
pharmacy to supplement in-house
pharmacy services, and/or (3) the
development of a network of 340B
covered entities. The intent was to allow
community health centers and other
340B safety-net providers to develop
new ways to improve access to 340B
prescription drugs for their patients.
From the time of the program’s
inception until the end of April 2006, a
total of 18 AMDPs were approved. Of
those, 11 utilize a multiple contract
pharmacies model, four establish a
network of 340B covered entities, one is
a combination of the network model and
the multiple contract pharmacies model,
one utilizes a contract pharmacy to
supplement an in-house pharmacy, and
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
one utilizes multiple contract
pharmacies to supplement an in-house
pharmacy. All but one of the projects is
currently ongoing. A condition of
AMDP approval is the requirement that
the approved demonstration project be
audited annually by an independent,
outside auditor for drug diversion and
duplicative discounts under Medicaid.
The results of the audits are required to
be reported to the Office of Pharmacy
Affairs (OPA). To date, there has been
no evidence of drug diversion or
duplicate manufacturer’s discounts on
340B drugs in the AMDP program.
HRSA, acting through OPA, is
proposing new guidelines that would
allow covered entities to utilize
multiple contract pharmacy service sites
and the utilization of a contract
pharmacy to supplement in-house
pharmacy services that were previously
limited to approved AMDPs. This
proposed change is due to the success
of the AMDPs, and the urging of safety
net providers who wish to utilize
alternatives to the single entity site/
single pharmacy location contractor
model to provide broader access to 340B
discounted drugs to eligible patient
populations. Other than permitting
these specified models, HRSA is not
proposing other substantive changes to
the contract pharmacy guidelines. The
AMDP process will continue for those
covered entities wishing to develop
340B networks of covered entities. OPA
will continue to review the utilization of
network demonstration projects and
consider adapting the rules to include
them in the future. Of particular
importance is the continued
requirement that appropriate procedures
be in place to prevent diversion of 340B
drugs or a duplicative 340B drug
discount and a Medicaid rebate on the
same drug, which are prohibited under
the statute.
These proposed guidelines replace all
sections of previous 340B Program
guidance documents addressing nonnetwork contract pharmacy services,
including, but not limited to, the
‘‘Notice Regarding Section 602 of the
Veterans Health Care Act of 1992;
Contract Pharmacy Services,’’ 61 FR
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[Federal Register Volume 72, Number 8 (Friday, January 12, 2007)]
[Notices]
[Pages 1539-1540]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-331]
[[Page 1539]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0528]
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
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 March 13, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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
21 CFR part 106 and part 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) (the 1996 proposed rule), FDA proposed changes in
the infant formula regulations, including some of those listed in
tables 1 and 2 of this document. The 1996 proposed rule 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section of the Federal Food, Drug, and Cosmetic Act No. of Annual Frequency per Total Annual Hours per
or 21 CFR Section Respondents Response Responses\2\ Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Section 412(d) of the act 5 13 65 10 650
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 106.120(b) 5 0.25 1.25 4 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.10(a) and 107.20 5 13 65 8 520
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(b)(3) and (b)(4) 3 2 6 4 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 107.50(e)(2) 3 0.33 1 4 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 1,203
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Manufacturers may submit infant formula notifications in electronic format.
[[Page 1540]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
106.100 5 10 50 4,000 200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
107.50(c)(3) 3 10 30 3,000 90,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 290,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. The figures
for hours per response are based on estimates from experienced persons
in the agency and in industry.
Dated: January 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-331 Filed 1-11-07; 8:45 am]
BILLING CODE 4160-01-S
