2046 Federal Register / Vol. 71, No.

8 / Thursday, January 12, 2006 / Notices

Users of NHAMCS data include, but industry, nonprofit foundations, additional three years. There are no
are not limited to, congressional offices, professional associations, clinicians, costs to the respondents other than their
Federal agencies, state and local researchers, administrators, and health time.
governments, schools of public health, planners. NCHS is seeking OMB
colleges and universities, private approval to extend this survey for an

ESTIMATED ANNUALIZED BURDEN TABLE

Number of Average bur-
Number of Total burden
Respondents responses/re- den/response
respondents (in hours)
spondent (in hours)

Hospital induction ............................................................................................ 490 1 55/60 449

ED induction .................................................................................................... 400 1 1 400
OPD induction .................................................................................................. 250 4 1 1,000
ED Patient record form .................................................................................... 400 100 5/60 3,333
OPD Patient record form ................................................................................. 250 200 5/60 4,167
CCSS ............................................................................................................... 250 1 15/60 63

Total ................................................................................................... ........................ ........................ ........................ 9,412

Dated: January 5, 2006. agency’s estimate of the burden of the community health centers (CHCs) were
Joan F. Karr, proposed collection of information; (c) added to the NAMCS sample, and these
Acting Reports Clearance Officer, Centers for ways to enhance the quality, utility, and data will continue to be collected in
Disease Control and Prevention. clarity of the information to be 2007–2008. To complement NAMCS
[FR Doc. E6–210 Filed 1–11–06; 8:45 am] collected; and (d) ways to minimize the data, NCHS initiated the National
BILLING CODE 4163–18–P burden of the collection of information Hospital Ambulatory Medical Care
on respondents, including through the Survey (NHAMCS, OMB No. 0920–
use of automated collection techniques 0278) to provide data concerning patient
DEPARTMENT OF HEALTH AND or other forms of information visits to hospital outpatient and
HUMAN SERVICES technology. Written comments should emergency departments.
be received within 60 days of this The NAMCS provides a range of
Centers for Disease Control and notice. baseline data on the characteristics of
Prevention the users and providers of ambulatory
Proposed Project
medical care. Data collected include the
[60Day–06–0234] National Ambulatory Medical Care patients’ demographic characteristics,
Survey (NAMCS) 2007–2008 (OMB No. reason(s) for visit, physicians’
Proposed Data Collections Submitted
0920–0234)—Extension—National diagnosis(es), diagnostic services,
for Public Comment and
Center for Health Statistics (NCHS), medications, and visit disposition. In
Recommendations
Centers for Disease Control and addition, a Cervical Cancer Screening
In compliance with the requirement Prevention (CDC). Supplement (CCSS) will continue to be
of section 3506(c)(2)(A) of the The NAMCS was conducted annually a key focus in 2007–2008. The CCSS
Paperwork Reduction Act of 1995 for from 1973 to 1981, again in 1985, and collects information on cervical cancer
opportunity for public comment on resumed as an annual survey in 1989. screening practices performed by
proposed data collection projects, the The purpose of NAMCS is to meet the selected physician specialties. It will
Centers for Disease Control and needs and demands for statistical allow the CDC/National Center for
Prevention (CDC) will publish periodic information about the provision of Chronic Disease Prevention and Health
summaries of proposed projects. To ambulatory medical care services in the Promotion to evaluate cervical cancer
request more information on the United States. Ambulatory services are screening methods and the use of
proposed projects or to obtain a copy of rendered in a wide variety of settings, human papillomavirus tests.
the data collection plans and including physicians’ offices and Users of NAMCS data include, but are
instruments, call 404–639–4766 and hospital outpatient and emergency not limited to, congressional offices,
send comments to Seleda Perryman, departments. The NAMCS target Federal agencies, state and local
CDC Assistant Reports Clearance population consists of all office visits governments, schools of public health,
Officer, 1600 Clifton Road, MS–D74, made by ambulatory patients to non- colleges and universities, private
Atlanta, GA 30333 or send an e-mail to Federal office-based physicians industry, nonprofit foundations,
omb@cdc.gov. (excluding those in the specialties of professional associations, clinicians,
Comments are invited on: (a) Whether anesthesiology, radiology, and researchers, administrators, and health
the proposed collection of information pathology) who are engaged in direct planners. NCHS is seeking OMB
is necessary for the proper performance patient care. For the first time in 2006, approval to extend this survey for an
of the functions of the agency, including physicians and mid-level providers (i.e., additional three years. There are no
whether the information shall have nurse practitioners, physician assistants, costs to the respondents other than their
practical utility; (b) the accuracy of the and nurse midwives) practicing in time.
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 Federal Register / Vol. 71, No. 8 / Thursday, January 12, 2006 / Notices 2047

ESTIMATED ANNUALIZED BURDEN TABLE

Number of Avg. burden/
Number of Total burden
Respondents responses/re- response
respondents hours
spondent (in hrs)

Office-based physicians:
Induction Interview .................................................................................... 3,350 1 28/60 1,563
Patient Record Form ................................................................................ 2,513 30 4/60 5,026
CCSS ........................................................................................................ 712 1 15/60 178
Community Health Center:
Induction Interview—Directors .................................................................. 104 1 20/60 35
Induction Interview—Providers ................................................................. 312 1 35/60 182
Patient Record Form ................................................................................ 312 30 5/60 780
CCSS ........................................................................................................ 312 1 15/60 78

Total ................................................................................................... ........................ ........................ ........................ 7,842

Dated: January 5, 2006. manufacturer, it is being made available (21 U.S.C. 355(j)(7)), which requires
Joan F. Karr, in certain instances of medical necessity FDA to publish a list of all approved
Acting Reports Clearance Officer, Centers for only. The reasons for its unavailability drugs. FDA publishes this list as part of
Disease Control and Prevention. are not safety or effectiveness the ‘‘Approved Drug Products With
[FR Doc. E6–211 Filed 1–11–06; 8:45 am] considerations associated with the drug Therapeutic Equivalence Evaluations,’’
BILLING CODE 4163–18–P product in general, but specific to the which is generally known as the
manufacturer. An ANDA applicant who ‘‘Orange Book.’’ Under FDA regulations,
is unable to obtain Celestone Soluspan drugs are withdrawn from the list if the
DEPARTMENT OF HEALTH AND injection for bioequivalence testing agency withdraws or suspends approval
HUMAN SERVICES must contact the Office of Generic Drugs of the drug’s NDA or ANDA for reasons
for a determination of what is necessary of safety or effectiveness, or if FDA
Food and Drug Administration to show bioavailability and same determines that the listed drug was
[Docket Nos. 2004P–0406 and 2004P–0407] therapeutic effect. If the reference listed withdrawn from sale for reasons of
drug (RLD) product becomes safety or effectiveness (21 CFR 314.162).
Determination That Celestone commercially available prior to ANDA Regulations also provide that the agency
Soluspan (Betamethasone Sodium approval, the ANDA applicant will need must make a determination as to
Phosphate and Betamethasone to show bioequivalence to the RLD whether a listed drug was withdrawn
Acetate) Injection and Celestone product. from sale for reasons of safety or
(Betamethasone Sodium Phosphate) FOR FURTHER INFORMATION CONTACT: effectiveness before an ANDA that refers
Injection Were Not Withdrawn From Carol E. Drew, Center for Drug to that listed drug may be approved
Sale for Reasons of Safety or Evaluation and Research (HFD–7), Food (§ 314.161(a)(1) (21 CFR 314.161(a)(1))).
Effectiveness and Drug Administration, 5600 Fishers FDA may not approve an ANDA that
Lane, Rockville, MD 20857, 301–594– does not refer to a listed drug.
AGENCY: Food and Drug Administration,
HHS. 2041. On September 7, 2004, Hikma
ACTION: Notice. SUPPLEMENTARY INFORMATION: In 1984, Farmaceutica (Portugal) LDA submitted
Congress enacted the Drug Price two citizen petitions (Docket Nos.
SUMMARY: The Food and Drug Competition and Patent Term 2004P–0406/CP1 and 2004P–0407/CP1)
Administration (FDA) is announcing its Restoration Act of 1984 (Public Law 98– to FDA under 21 CFR 10.30 requesting
determination that two drug products— 417) (the 1984 amendments), which that the agency determine whether
Celestone Soluspan (betamethasone authorized the approval of duplicate Celestone Soluspan (betamethasone
sodium phosphate and betamethasone versions of drug products approved sodium phosphate and betamethasone
acetate) injection and Celestone under an ANDA procedure. ANDA acetate) injection equivalent to 6
(betamethasone sodium phosphate) sponsors must, with certain exceptions, milligrams (mg) base/milliliter (mL)
injection—were not withdrawn from show that the drug for which they are (NDA 14–602) and Celestone
sale for reasons of safety or seeking approval contains the same (betamethasone sodium phosphate)
effectiveness. This determination will active ingredient in the same strength injection equivalent to 3 mg base/mL
allow FDA to approve abbreviated new and dosage form as the ‘‘listed drug,’’ (NDA 17–561), both manufactured by
drug applications (ANDAs) for which is a version of the drug that was Schering-Plough Corp. (Schering), were
betamethasone sodium phosphate and previously approved under a new drug withdrawn from sale for reasons of
betamethasone acetate injection and application (NDA). Sponsors of ANDAs safety or effectiveness. Celestone
betamethasone sodium phosphate do not have to repeat the extensive Soluspan injection and Celestone
injection if all other legal and regulatory clinical testing otherwise necessary to injection are corticosteroids used for
requirements are met. However, in gain approval of an NDA. The only their anti-inflammatory effects in
considering whether to file an ANDA for clinical data required in an ANDA are disorders of many organ systems.
betamethasone sodium phosphate and data to show that the drug that is the Schering ceased manufacture of
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betamethasone acetate injection, future subject of the ANDA is bioequivalent to Celestone injection in March 2004, and
applicants are advised that Celestone the listed drug. it was moved from the prescription drug
Soluspan injection may not be The 1984 amendments include what product list to the ‘‘Discontinued Drug
commercially available because, under a is now section 505(j)(7) of the Federal Product List’’ section of the Orange
consent decree between FDA and the Food, Drug, and Cosmetic Act (the act) Book.

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