Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements, 14116-14118 [E7-5470]
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14116
Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
412(a)(4) of the Immigration and
Nationality Act, which provides that
‘‘no grant or contract may be awarded
under this section unless an appropriate
proposal and application * * * are
submitted to, and approved by, the
appropriate administering official.’’
Respondents: State Governments.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR–1 .............................................................................................................
48
1
.5
24
Estimated Total Annual Burden
Hours: 24.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Information Services,
370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 20, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1462 Filed 3–23–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Uniform Project Description
(UPD) for Discretionary Grant
Application Form.
OMB No.: 0970–0139.
Description: The Administration for
Children and Families (ACF) has more
than 40 discretionary grant program.
This information collection form will be
a uniform discretionary application
form unable for all of these grant
programs to collect the information from
grant applicants needed to evaluate and
rank applicants and protect the integrity
of the grantee selection process. All ACF
discretionary grant programs would be
eligible but not required to use this
application form. The application
consists of general information and
instructions; the Standard Form 424
series that requests basic information,
budget information and assurances; the
Program Narrative requesting the
applicant to describe how these
objections will be reached; and
certifications. Guidance for the content
of information requested in the Program
Narrative is found in OMB Circulars A–
102 and A–110.
Respondents: Applicants for ACF
Discretionary Grant Programs.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
UPD .................................................................................................................
cprice-sewell on PROD1PC66 with NOTICES
Instrument
4,133
1
40
165,320
Estimated Total Annual Burden
Hours: 165,320.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make decision concerning the collection
of information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
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is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for, Children and
Families.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 20, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1463 Filed 3–23–07; 8:45 am]
AGENCY:
BILLING CODE 4184–07–M
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Food and Drug Administration
[Docket No. 2006N–0528]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Requirements
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
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.
Fax written comments on the
collection of information by April 25,
2007.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Infant Formula Requirements (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.
In the Federal Register of January 12,
2007 (72 FR 1539), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
The notice incorrectly reported the
‘‘Hours per Record’’ and the ‘‘Total
Hours’’ for 21 CFR 106.100 and
107.50(c)(3) in Table 2. Table 2 of this
document contains the correct burden
estimate.
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
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses2
Hours per
Response
Total Hours
Section 412(d) of the act
5
13
65
10
650
106.120(b)
1
1
1
4
4
107.10(a) and 107.20
5
13
65
8
520
107.50(b)(3) and (b)(4)
3
2
6
4
24
107.50(e)(2)
1
1
1
4
4
Total
1There
1,202
are no capital costs or operating and maintenance costs associated with this collection of information.
may submit infant formula notifications in electronic format.
2Manufacturers
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
per Recordkeeping
Total Annual
Records2
Hours per
Record
Total Hours
106.100
5
10
50
400
20,000
107.50 (c)(3)
3
10
30
300
9,000
Total
cprice-sewell on PROD1PC66 with NOTICES
1There
29,000
are no capital costs or operating and maintenance costs associated with this collection of information.
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14118
Federal Register / Vol. 72, No. 57 / Monday, March 26, 2007 / Notices
Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5470 Filed 3–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0255]
Determination That DURICEF
(Cefadroxil USP) Tablets, 1 Gram, and
Capsules, 500 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that DURICEF (cefadroxil USP) Tablets,
1 gram (g), and Capsules, 500 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
continue to approve abbreviated new
drug applications (ANDAs) for
cefadroxil USP tablets, 1 g, and
cefadroxil USP capsules, 500 mg.
FOR FURTHER INFORMATION CONTACT:
Mary Catchings, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is typically a version of the drug
that was previously approved. Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetics Act (21
U.S.C. 355(j)(7)), which requires FDA to
publish a list of all approved drugs.
cprice-sewell on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
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FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness, or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a), the
circumstances under which the agency
must determine whether a listed drug
was withdrawn from sale for reasons of
safety or effectiveness include: (1)
Before an ANDA that refers to that listed
drug may be approved and (2) whenever
a listed drug is voluntarily withdrawn
from sale, and ANDAs that refer to the
listed drug have been approved. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA may not approve an ANDA that
does not refer to a listed drug.
DURICEF (cefadroxil USP) Tablets, 1
g, and Capsules, 500 mg, are the subjects
of approved NDA 50–528 and NDA 50–
512, respectively, held by Warner
Chilcott, Inc. (Warner Chilcott).
DURICEF is an antibiotic indicated to
treat infections of the urinary tract, skin,
throat, and tonsils, caused by specific
bacteria, including streptococci,
staphylococci, and Escherichia coli.
Warner Chilcott has informed FDA that
DURICEF (cefadroxil USP) Tablets 1 g,
and Capsules, 500 mg, have been
withdrawn from sale.
In a citizen petition dated June 13,
2006 (Docket No. 2006P–0255/CP1),
submitted under 21 CFR 10.30, Orchid
Healthcare (a division of Orchid
Chemicals & Pharmaceuticals Ltd.)
requested that the agency determine
whether DURICEF (cefadroxil USP)
Tablets, 1 g, were withdrawn from sale
for reasons of safety or effectiveness. In
addition, there are approved ANDAs
that refer to DURICEF (cefadroxil USP)
Tablets, 1 g, and Capsules, 500 mg.
The agency has determined that
Warner Chilcott’s DURICEF (cefadroxil
USP) Tablets, 1 g, and Capsules, 500 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. The
petitioner identified no data or other
information suggesting that DURICEF
Tablets, 1 g, and Capsules, 500 mg, were
withdrawn from sale for reasons of
safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
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postmarketing adverse events and has
found no information that would
indicate that either DURICEF Tablets, 1
g, or Capsules, 500 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that, for the reasons outlined
in this document, DURICEF (cefadroxil
USP) Tablets, 1 g, and Capsules, 500 mg,
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the agency will continue
to list DURICEF (cefadroxil USP)
Tablets, 1 g, and Capsules, 500 mg, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. Approved
ANDAs that refer to DURICEF cefadroxil
USP) Tablets, 1 g, and Capsules, 500 mg,
are unaffected by the withdrawal of
these products from sale. ANDAs that
refer to cefadroxil USP (tablets, 1 g, and
cefadroxil USP capsules, 500 mg, may
be approved by the agency as long as
they meet all relevant legal and
regulatory requirements for the approval
of ANDAs.
Dated: March 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–5415 Filed 3–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0240]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; REVLIMID
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
REVLIMID and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
E:\FR\FM\26MRN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Pages 14116-14118]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0528]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Infant Formula
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing
[[Page 14117]]
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 April
25, 2007.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Infant Formula Requirements (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.
In the Federal Register of January 12, 2007 (72 FR 1539), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received. The notice
incorrectly reported the ``Hours per Record'' and the ``Total Hours''
for 21 CFR 106.100 and 107.50(c)(3) in Table 2. Table 2 of this
document contains the correct burden estimate.
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 Total Hours
Section Respondents per Response Responses\2\ Response
----------------------------------------------------------------------------------------------------------------
Section 412(d) of the act 5 13 65 10 650
----------------------------------------------------------------------------------------------------------------
106.120(b) 1 1 1 4 4
----------------------------------------------------------------------------------------------------------------
107.10(a) and 107.20 5 13 65 8 520
----------------------------------------------------------------------------------------------------------------
107.50(b)(3) and (b)(4) 3 2 6 4 24
----------------------------------------------------------------------------------------------------------------
107.50(e)(2) 1 1 1 4 4
----------------------------------------------------------------------------------------------------------------
Total .............. ................. ................. .............. 1,202
----------------------------------------------------------------------------------------------------------------
\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.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records\2\ Record Total Hours
----------------------------------------------------------------------------------------------------------------
106.100 5 10 50 400 20,000
----------------------------------------------------------------------------------------------------------------
107.50 (c)(3) 3 10 30 300 9,000
----------------------------------------------------------------------------------------------------------------
Total ................. .................... .................... .............. 29,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 14118]]
Dated: March 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5470 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S
