55873Federal Register / Vol. 63, No. 201 / Monday, October 19, 1998 / Notices
SUPPLEMENTARY INFORMATION: Proposal
to renew the following currently
approved collection of information:
Title: Flood Insurance.
OMB Number: 3064–0120.
Frequency of Response: As needed.
Affected Public: Any depository
institution whose borrower’s loan
requests were secured by a building
located on property in a special flood
hazard area.
Estimated Number of Respondents:
6,000.
Estimated Time per Respondent: 25.9
hours.
Estimated Total Annual Burden:
155,625.
General Description of Collection:
Each supervised lending institution is
currently required to provide a notice of
special flood hazards to a borrower
acquiring a loan secured by a building
on real property located in an area
identified by the Director of the Federal
Emergency Management Administration
as being subject to special flood hazards.
The Riegle Community Development
and Regulatory Improvement Act
requires that each institution must also
provide a copy of the notice to the
servicer of the loan (if different from the
originating lender).
Request for Comment
Comment are invited on: (a) whether
the collection of information is
necessary for the proper performance of
the FDIC’s functions, including whether
the information has practical utility; (b)
the accuracy of the estimates of the
burden of the information collection,
including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the information collection on
respondents, including through the use
of automated collection techniques of
other forms of information technology.
At the end of the comment period, the
comments and recommendations
received will be analyzed to determine
the extent to which the collection
should be modified prior to submission
to OMB for review and approval.
Comments submitted in response to this
notice also will be summarized or
included in the FDIC’s requests to OMB
for renewal of this collection. All
comments will become a matter of
public record.
Dated at Washington, DC this 13th day of
October, 1998.
Federal Deposit Insurance Corporation.
Rober E. Feldman,
Executive Secretary.
[FR Doc. 98–27883 Filed 10–16–98; 8:45 am]
BILLING CODE 6714–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 98P–0086]
Determination That Sutilains Ointment
USP Was Not Withdrawn From Sale for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) is announcing its
determination that sutilains ointment
USP (Travase Ointment) was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDA’s) for sutilains
ointment USP.
FOR FURTHER INFORMATION CONTACT:
Andrea C. Masciale, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
5648.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 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 a version of the drug that was
previously approved under a new drug
application (NDA). Sponsors of ANDA’s
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of an 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 included what
is now section 505(j)(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(6)), which requires FDA to
publish a list of all approved drugs.
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).
Regulations also provide that the agency
must make a determination as to
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness before an ANDA that refers
to that listed drug may be approved
(314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On February 11, 1998, Hogan &
Hartson, L.L.P. submitted a citizen
petition (Docket No. 98P–0086/CP1)
under 21 CFR 10.30 to FDA requesting
that the agency determine whether
sutilains ointment USP was withdrawn
from sale for reasons of safety or
effectiveness. Sutilains ointment USP
(Travase Ointment) is the subject of
NDA 12–828. FDA approved NDA 12–
828, held by Travenol Laboratories, on
June 12, 1969. The right to market
sutilains ointment USP was
subsequently transferred to Boots
Pharmaceuticals, Inc., which became
part of Knoll Pharmaceuticals (Knoll) on
April 1, 1995. Knoll stopped
distribution of the drug product
effective March 29, 1996.
FDA has reviewed its records and,
under § 314.161, has determined that
Knoll’s decision not to market sutilains
ointment USP was not for reasons of
safety or effectiveness. Accordingly, the
agency will move sutilains ointment
USP to 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. ANDA’s that
refer to sutilains ointment USP may be
approved by the agency.
Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy
Coordination.
[FR Doc. 98–27889 Filed 10–16–98; 8:45 am]
BILLING CODE 4160–01–F
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N–0864]
Privacy Act of 1974; Altered System of
Records, Including Addition of Routine
Use(s) to an Existing System of
Records
AGENCY: Department of Health and
Human Services (HHS).
55874 Federal Register / Vol. 63, No. 201 / Monday, October 19, 1998 / Notices
ACTION: Notification of an altered system
of records, including the addition of a
new routine use.
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974
(Privacy Act), the Department of Health
and Human Services (HHS) is
publishing notice of a proposal to alter
Privacy Act System of Records 09–10–
0010 for the ‘‘Bioresearch Monitoring
Information System, HHS/FDA,’’
including the addition of a new routine
use. The major purposes of the proposed
alterations are to add the names of the
Center for Food Safety and Applied
Nutrition (CFSAN), and the Center for
Veterinary Medicine (CVM), and related
information regarding these Centers, to
ensure that the system covers all of the
Food and Drug Administration’s (FDA’s)
Centers; update the relevant statutory
and regulatory citations; and modify the
routine uses section of the existing
system notice by removing unnecessary
routine uses, revising other routine uses
to bring them in conformance with case
law, and adding a new routine use
providing for disclosure of covered
records to sponsors and Institutional
Review Boards (IRB’s) involved with
studies affected by a clinical
investigator’s violative or potentially
violative conduct.
DATES: Submit written comments on the
proposed alterations, including the new
routine use, by November 18, 1998.
HHS sent a Report of Altered System to
the Congress and the Office of
Management and Budget (OMB) on
October 19, 1998. The alteration to the
system of records will be effective 40
days from the date submitted to OMB
unless HHS receives comments which
would result in a contrary
determination.
ADDRESSES: Submit written comments
to the Dockets Management Branch
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regulatory Counsel (HFC–230), Office of
Regulatory Affairs, Office of
Enforcement, Division of Compliance
Policy, Food and Drug Administration,
12720 Twinbrook Pkwy., suite 517,
Rockville, MD 20852, 301–827–0412.
SUPPLEMENTARY INFORMATION: FDA
proposes to alter Privacy Act System of
Records 09–10–0010 for the
‘‘Bioresearch Monitoring Information
System, HHS/FDA.’’ The major
purposes of the proposed alterations are
to: (1) Add the names of CFSAN, and
CVM, and related information regarding
these Centers, to ensure that the system
covers all of FDA’s Centers; (2) update
the relevant statutory and regulatory
citations; and (3) modify the routine
uses section of the existing system
notice by removing unnecessary routine
uses, revising other routine uses to bring
them in conformance with case law, and
adding a new routine use providing for
disclosure of covered records to
sponsors and IRB’s involved with
studies affected by a clinical
investigator’s violative or potentially
violative conduct.
The records in this system will be
maintained in a secure manner
compatible with their content and use.
All records are kept in secured areas,
locked rooms, and locked buildings.
Manual and computerized records will
be maintained in accordance with the
standards of Chapter 45–13 of the HHS
General Administration Manual,
‘‘Safeguarding Records Contained in
Systems of Records,’’ supplementary
Chapter PHS hf: 45–13 of the
Department’s General Administration
Manual, and the Department’s
Automated Information Systems
Security Handbook. Data stored in
computers will be accessed through the
use of regularly expiring passwords and
individual ID’s known only to
authorized users.
FDA staff will be required to adhere
to the provisions of the Privacy Act (5
U.S.C. 552a) and the HHS Privacy Act
regulations (45 CFR 5b). Only
authorized users whose official duties
require the use of such information will
have regular access to the records in this
system. Authorized users are FDA
employees and contractors responsible
for training the individuals who will
inspect the facilities of the clinical
investigators, who compile and analyze
the inspectional data and information,
or who, as a part of their official duties,
routinely disclose information under the
Freedom of Information Act (FOIA) or
conduct other authorized sharing of
FDA records. Users will be required to
sign an agreement indicating their
cooperation with FDA systems security
and Privacy Act policies.
The proposed alteration contains a
new routine use permitting disclosure of
records in the system to sponsors and
IRB’s associated with the clinical
investigator’s studies. Under the altered
system, FDA may disclose to sponsors
and IRB’s those records that on their
face, or in conjunction with other
records, indicate a violation or potential
violation of the law by clinical
investigators that have conducted or are
conducting studies. Disclosure would be
made either under a request from the
sponsor or IRB or, in FDA’s discretion,
without the need for a request. The
purpose of disclosure would be to alert
these parties to inspectional findings
indicating violations or potential
violations of the laws enforced by FDA,
including the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321 et seq.) and
its implementing regulations. Such
disclosure is compatible with the
purpose of the system because the
sponsors and IRB’s play a significant
role in ensuring that clinical
investigators meet the applicable
statutory and regulatory requirements.
Disclosure also provides the sponsors
and IRB’s with information that is
important to meeting their
responsibilities under FDA’s
regulations, including their
responsibility to monitor the data
collected under the study.
In some cases, evidence of a violation
or potential violation may implicate
more than one of the clinical
investigator’s studies. Where more than
one clinical study is involved, FDA
may, where it deems appropriate, share
information concerning a violation or
potential violation with the sponsors
and IRB’s of any of the clinical
investigator’s studies.
In addition to creating a new routine
use, the proposed alteration will delete
as unnecessary two routine uses which
provide for disclosure of records to
certain employees of the agency for use
in performance of their duties, thereby
duplicating another Privacy Act
exemption, 5 U.S.C. 552a(b)(1). The
proposed alteration also will revise
language in the remaining routine uses
to bring them in conformance with
recent case law. (See Covert v.
Harrington, 876 F.2d 751 (9th Cir.
1989).) Minor editorial revisions also
have been made throughout the system
notice to enhance its clarity and
specificity, and to accommodate normal
updating changes.
Interested persons may, on or before
(insert date 30 days after date of
publication in the Federal Register),
submit to the Dockets Management
Branch (address above) written
comments regarding the revised system
notice. Two copies of any comments are
to be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the office above between 9 a.m.
and 4 p.m., Monday through Friday.
The following notice is written in the
present, rather than the future tense, to
avoid the unnecessary expenditure of
public funds to republish the notice
after the alteration and routine use has
become effective. The revised system
notice, including the proposed
alterations, is set forth in full below.
55875Federal Register / Vol. 63, No. 201 / Monday, October 19, 1998 / Notices
Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy
Coordination.
Revised System Notice
09–10–0010
SYSTEM NAME:
Bioresearch Monitoring Information
System, HHS/FDA.
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
Center for Biologics Evaluation and
Research (CBER), Office of Compliance
and Biologics Quality, Bioresearch
Monitoring Team (HFM–650), 1401
Rockville Pike, Rockville, MD 20852.
Center for Devices and Radiological
Health (CDRH), Office of Compliance,
Division of Bioresearch Monitoring
(HFZ–310), 2094 Gaither Rd., Rockville,
MD 20850.
Center for Drug Evaluation and
Research (CDER), Office of Compliance,
Division of Scientific Investigations
(HFD–340), 7520 Standish Pl.,
Rockville, MD 20855.
Center for Food Safety and Applied
Nutrition (CFSAN), Office of Premarket
Approval, Division of Product Policy
(HFS–205), 200 C St. SW., Washington,
DC 20204.
Center for Veterinary Medicine
(CVM), Office of Surveillance &
Compliance (HFV–234), Division of
Compliance, Bioresearch Monitoring
Staff, 7500 Standish Pl., Rockville, MD
20855.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Clinical investigators who are
conducting, or have conducted, clinical
studies of new drugs, biologics, and
devices under investigational new drug
and biologics, and investigational
device exemption requests; clinical
investigators who are conducting, or
have conducted, studies on food or
color additives, generally recognized as
safe (GRAS) substances, or infant
formula; and clinical investigators who
are conducting, or have conducted,
studies on new animal drugs under
investigational new animal drug
requests.
CATEGORIES OF RECORDS IN THE SYSTEM:
Automated file is maintained on all
clinical investigators; contains name,
education, professional qualifications
and background, Program Oriented Data
Systems (PODS) locator code, and
information on studies conducted.
Manual file contains, in addition to that
same information, investigatory material
collected by, or developed by, the Food
and Drug Administration (FDA), during
investigations of possible violations of
statutes and regulations governing new
drug, biologic, food or color additive,
GRAS substance, infant formula, new
animal drug, and/or device studies.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
Section 505(i)(3), Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)(3)),
21 CFR part 312 (new drugs and
biologics for investigational use);
Section 520, Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), 21 CFR
part 812 (new devices for investigational
use); Sections 512(j) and (l)(1), Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360b(j) and (l)(1)), 21 CFR part 511 (new
animal drugs for investigational use);
Sections 409 and 721, Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348
and 379e), 21 CFR part 71 (color
additive petitions), 21 CFR part 171
(food additive petitions); Section 412,
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350a) (infant formula
requirements); and Section 351, Public
Health Service Act (42 U.S.C. 262).
PURPOSE(S):
1. To provide controls to assure that
investigators meet requirements of the
relevant statutes and regulations
governing new drug, biologic, food or
color additive, GRAS substance, infant
formula, new animal drug, and/or
device studies.
2.To serve as a data base for the
effective performance of activities
necessary for the conduct of the
bioresearch monitoring program.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
1. Records that, on their face or in
conjunction with other records, indicate
a violation or potential violation of law,
may be: (1) Referred for investigation
and possible enforcement action under
the applicable Federal, State, or foreign
laws to the Department of Justice and
other appropriate Federal agencies, an
appropriate State food and drug
enforcement agency or licensing
authority, or the government of a foreign
country where studies are being or have
been conducted; or (2) disclosed to
sponsors or IRB’s responsible for
initiating, approving, monitoring, or
overseeing any studies affected by the
violation or potential violation, if the
information disclosed is relevant to any
enforcement, regulatory, investigative,
or prosecutorial responsibility of the
receiving entity.
2. Disclosure may be made to a
congressional office from the record of
an individual in response to an inquiry
from the congressional office made at
the written request of that individual.
3. The Department of Health and
Human Services (HHS) may disclose
information from this system of records
to the Department of Justice, or to a
court or other adjudicative body, when:
(a) HHS, or any component thereof; or
(b) Any HHS employee in his or her
official capacity; or
(c) Any HHS employee in his or her
individual capacity where the
Department of Justice (or HHS, where it
is authorized to do so) has agreed to
represent the employee; or
(d) The United States or any agency
thereof (where HHS determines that the
litigation is likely to affect HHS or any
of its components),
is a party to litigation or has an
interest in such litigation, and HHS
determines that the use of such records
by the Department of Justice, the court
or other adjudicative body, is relevant
and necessary to the litigation and
would help in the effective
representation of the governmental
interest, provided, however, that in each
case, HHS determines that such
disclosure is compatible with the
purpose for which the records were
collected.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Manual files of investigatory materials
are maintained in letter-size manila
folders and on microfilm. Automated
files are maintained on magnetic disk or
tape.
RETRIEVABILITY:
Indexed by name or code number.
SAFEGUARDS:
1.Authorized users: Personnel in
CBER’s Bioresearch Monitoring Team
and CBER Product Review Offices;
Personnel in CDRH’s Division of
Bioresearch Monitoring; Personnel in
CDER’s Division of Scientific
Investigations, Division of Drug
Information Resources, Management
and Data Systems Branch; Personnel in
CFSAN’s Division of Product Policy,
Division of Health Effects Evaluation;
and Personnel in CVM’s Division of
Compliance, Bioresearch Monitoring
Staff.
2.Physical safeguards: Files are stored
in secured areas, locked buildings,
locked rooms, locked tape vaults, and
lockable data media cabinets.
3.Procedural (or technical)
safeguards: Limited access and
computer password which is changed
periodically.
55876 Federal Register / Vol. 63, No. 201 / Monday, October 19, 1998 / Notices
4.Implementation guidelines: These
practices are in compliance with the
standards of chapter 45–13 of the HHS
General Administration Manual,
‘‘Safeguarding Records Contained in
Systems of Records,’’ supplementary
Chapter PHS hf: 45–13, and the
Department’s Automated Information
System Security Handbook.
RETENTION AND DISPOSAL:
Records are retained and disposed of
under the authority of the FDA Records
Control Schedule transmittal number
H:90–1, Departmental number B–331.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Inspections and
Surveillance (HFM–650), Center for
Biologics Evaluation and Research,
Office of Compliance and Biologics
Quality, 1401 Rockville Pike, Rockville,
MD 20852.
Director, Division of Bioresearch
Monitoring (HFZ–310), Office of
Compliance, Center for Devices and
Radiological Health, 2094 Gaither Rd.,
Rockville, MD 20850.
Deputy Director, Division of Scientific
Investigation (HFD–341), Center for
Drug Evaluation and Research, Office of
Compliance, 7520 Standish Pl.,
Rockville, MD 20855.
Bioresearch Monitoring Project
Manager (HFS–207), Center for Food
Safety and Applied Nutrition, Office of
Premarket Approval, Division of
Product Policy, 200 C St. SW.,
Washington, DC 20204.
Manager, Bioresearch Monitoring
Program (HFV–234), Center for
Veterinary Medicine, Division of
Compliance, 7500 Standish Pl.,
Rockville, MD 20855.
NOTIFICATION PROCEDURES:
An individual may learn if a record
exists about him or her upon written
request with notarized signature or
certification of identification under
penalty of perjury if request is made by
mail, or with identification if request is
made in person (see also 21 CFR 21.44),
directed to:
FDA Privacy Act Coordinator (HFI–
30), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857.
RECORD ACCESS PROCEDURES:
Same as notification procedures.
Requesters should also reasonably
specify the record contents being
sought. Access to record systems which
have been granted an exemption from
the Privacy Act access requirement may
be made at the discretion of the system
manager. If access is denied to requested
records, an appeal may be made to:
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857.
You may also request an accounting
of disclosures that have been made of
your record, if any.
CONTESTING RECORD PROCEDURES:
Contact the official at the address
specified under notification procedures
above and reasonably identify the
record, specify the information being
contested, the corrective action sought,
and your reasons for requesting the
correction, along with supporting
information to show how the record is
inaccurate, incomplete, untimely, or
irrelevant.
RECORD SOURCE CATEGORIES:
Individual on whom the record is
maintained. Some material is obtained
from third parties, e.g., drug companies,
publications, or is developed by FDA.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
This system is exempt from access
and contest and certain other provisions
of the Privacy Act (5 U.S.C. 552a(c)(3),
(d)(1) to (d)(4), (e)(3), (e)(4)(G) to
(e)(4)(H) and (f)) to the extent that it
includes investigatory material
compiled for law enforcement purposes,
where access would be likely to
prejudice the conduct of the
investigation.
[FR Doc. 98–27937 Filed 10–16–98; 8:45 am]
BILLING CODE 4160–01–F
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N–0135]
Agency Information Collection
Activities; Announcement of OMB
Approval; OTC Test Sample Collection
Systems for Drugs of Abuse Testing
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘OTC Test Sample Collection Systems
for Drugs of Abuse Testing’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA).
FOR FURTHER INFORMATION CONTACT:
Margaret R. Schlosburg, Office of
Information Resources Management
(HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 5, 1998 (63
FR 10792), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under section 3507 of the PRA
(44 U.S.C. 3507). An agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0368. The
approval expires on April 30, 2001.
Dated: October 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy
Coordination.
[FR Doc. 98–27887 Filed 10–16–98; 8:45 am]
BILLING CODE 4160–01–F
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D–0514]
Draft Guidance for Industry on
ANDA’s: Impurities in Drug
Substances; Availability; Reopening of
Comment Period
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice; reopening of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
November 23, 1998, the comment
period for the draft guidance for
industry entitled ‘‘ANDA’s: Impurities
in Drug Substances.’’ FDA published a
notice of availability of the draft
guidance in the Federal Register of July
24, 1998 (63 FR 39880). FDA is taking
this action in response to several
requests for an extension.
DATES: Written comments on the draft
guidance may be submitted by
November 23, 1998. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Copies of the draft guidance
are available on the Internet at ‘‘http://
www.fda.gov/cder/guidance/
index.htm’’. Submit written requests for
single copies of the draft guidance to the
Drug Information Branch (HFD–210),
Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-
addressed adhesive label to assist that
office in processing your requests.
Submit written comments on the draft