
[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48175-48177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0779]


Retrospective Review of Draft Guidance Documents Issued Before 
2010; Withdrawal of Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
initiative in the Center for Drug Evaluation and Research (CDER) 
involving the review of draft guidance documents issued before 2010 to 
determine their status, and to decide whether those guidances should be 
withdrawn, revised, or finalized with only minor changes. Guidances 
that are no longer up to date, and for which more current information 
is available, will be withdrawn. Guidances that reflect CDER's current 
thinking, CDER will decide whether to revise or finalize. This notice 
describes CDER's initiative, announces the first group of guidances to 
be withdrawn, describes in general terms draft guidances under 
consideration for revision or finalization, and explains how CDER is 
making this process as transparent as possible.

DATES: General comments on Agency guidance documents are welcome at any 
time.

ADDRESSES: Submit electronic comments on Agency guidance documents to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY 
INFORMATION section for electronic access to Agency guidance documents.

FOR FURTHER INFORMATION CONTACT: Kimberly K. Thomas, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357, kimberly.k.thomas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In September 2000, FDA issued the final rule ``Administrative 
Practices and Procedures; Good Guidance Practices'' (GGP) (65 FR 56468; 
September 19, 2000). The GGP regulation describes FDA policies and 
procedures for the development, issuance, and use of guidance documents 
and makes these Agency policies and procedures clear to the public. The 
GGP regulation provides for developing and issuing guidances that set 
forth initial interpretations of statutory or regulatory requirements, 
explain changes in interpretation of policies that are of other than 
minor in nature, or discuss complex scientific issues or highly 
controversial issues. The GGP regulation also requires that such 
guidances be issued in draft for public comment before they are 
finalized (Level 1 guidances). In addition, the GGP regulation explains 
that FDA will periodically review existing guidance documents to 
determine whether they need to be changed or withdrawn.
    A key component of the GGP regulation is ensuring transparency 
during guidance development and issuance. Since finalization of the GGP 
regulation in September 2000, CDER has issued an average of 
approximately 20 draft guidances each year, seeking public input and 
carefully considering that input before issuing final versions of the 
guidances. In many cases, guidances were not finalized most often 
because of higher staff priorities. However, over the years, because of 
new information, scientific developments, and emerging technologies, 
draft guidances were also revised, and reissued or withdrawn.\1\
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    \1\ When Level 1 guidances are revised, they are usually issued 
as draft, version 2s, for public input before being issued in final 
form. When a guidance needs to be withdrawn, a notice is sometimes 
published in the Federal Register announcing that the guidance has 
been withdrawn. If no withdrawal announcement is made, CDER 
maintains a current list of new/revised/withdrawn guidances on the 
CDER guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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    Recently, CDER launched an initiative to review draft guidance 
documents published before 2010 to decide which guidances to withdraw, 
revise, or finalize with only minor changes. CDER is withdrawing draft 
guidances that are no longer up to date. CDER is also actively 
reviewing the draft guidances to determine which ones to either revise 
or finalize. This notice lists the first group of guidances CDER has 
identified for withdrawal, describes generally what guidances are being 
reviewed, and describes how CDER will keep the public informed of the 
guidances that are available with the goal of making the initiative 
transparent and consistent with the GGP regulation (21 CFR 10.115).

II. Withdrawal of Guidances

    CDER has reviewed many draft guidances published before 2010. As a 
result of this review, CDER identified 23 draft guidances for 
withdrawal. The guidances are being withdrawn because they are out of 
date, thus of little use to the pharmaceutical industry. In most cases, 
FDA has developed other guidances and resources to assist industry with 
clinical evaluation and requirements for drug approval. The guidances 
identified for withdrawal relate to these topics:
     Current good manufacturing practice (cGMP) compliance 
specific to manufacturing, processing, and dose unit sampling and 
assessment;
     Development of antimicrobial drugs for the treatment of 
acute bronchitis, bacterial meningitis, bacterial prostatitis, 
bacterial vaginosis, catheter-related bloodstream infections, febrile 
neutropenia, gonorrhea, Lyme disease, streptococcal pharyngitis and 
tonsillitis, uncomplicated urinary tract infections, and vuvlovaginal 
candidiasis;
     Clinical trials for developing antimicrobial drugs and 
packaging of

[[Page 48176]]

inhalation products in semipermeable container systems;
     Approval of abbreviated new drug applications (ANDAs) and 
505(b)(2) applications under the Drug Price Competition and Patent Term 
Restoration Act of 1984 (i.e., the Hatch-Waxman Act);
     Procedures relating to submission of patent information, 
submission of marketing applications, and forms for registration and 
disclosure of information;
     Labeling in ANDAs; and
     Qualifying for pediatric exclusivity under the Best 
Pharmaceuticals for Children Act.
    CDER is withdrawing the following guidances:

1. ``Manufacturing, Processing, or Holding Active Pharmaceutical 
Ingredients''--issued April 1998.
2. ``Powder Blends and Finished Dosage Units--Stratified In-Process 
Dosage Unit Sampling and Assessment''--issued November 2003.
3. ``Forms for Registration of Producers of Drugs and Listing of Drugs 
in Commercial Distribution''--issued May 2001.
4. ``Disclosing Information Provided to Advisory Committees in 
Connection With Open Advisory Committee Meetings Related to the Testing 
or Approval of New Drugs and Convened by CDER, Beginning on January 1, 
2000''--issued December 1999.

    For information on the four preceding guidances, contact the Office 
of Compliance in CDER.

5. ``Evaluating Clinical Studies of Antimicrobials in the Division of 
Anti-Infective Drug Products''--issued February 1997.
6. ``Empiric Therapy of Febrile Neutropenia--Developing Antimicrobial 
Drugs for Treatment''--issued July 1998.
7. ``Lyme Disease--Developing Antimicrobial Drugs for Treatment''--
issued July 1998.
8. ``Secondary Bacterial Infections of Acute Bronchitis--Developing 
Antimicrobial Drugs for Treatment''--issued July 1998.
9. ``Streptococcal Pharyngitis and Tonsillitis--Developing 
Antimicrobial Drugs for Treatment''--issued July 1998.
10. ``Uncomplicated Gonorrhea--Developing Antimicrobial Drugs for 
Treatment''--issued July 1998.
11. ``Uncomplicated Urinary Tract Infections--Developing Antimicrobial 
Drugs for Treatment''--issued July 1998.
12. ``Vulvovaginal Candidiasis--Developing Antimicrobial Drugs for 
Treatment''--issued July 1998.
13. ``Bacterial Vaginosis--Developing Antimicrobial Drugs for 
Treatment''--issued July 1998.
14. ``Acute Bacterial Meningitis--Developing Antimicrobial Drugs for 
Treatment''--issued July 1998.
15. ``Acute or Chronic Bacterial Prostatitis--Developing Antimicrobial 
Drugs for Treatment''--issued July 1998.
16. ``Developing Antimicrobial Drugs--General Considerations for 
Clinical Trials''--issued July 1998.
17. ``Catheter-Related Bloodstream Infections--Developing Antimicrobial 
Drugs for Treatment''--issued October 1999.

    For information on the preceding 13 guidances (number 5 through 
17), contact the Office of Antimicrobial Products in the Office of New 
Drugs in CDER.

18. ``Labeling Over-the-Counter (OTC) Human Drug Products--Updating 
Labeling in ANDAs''--issued February 2001.

    For information on the preceding guidance (number 18), contact the 
Office of Drug Evaluation IV in the Office of New Drugs in CDER.

19. ``Inhalation Drug Products Packaged in Semipermeable Container 
Closure Systems''--issued July 2002.
20. ``Listed Drugs, 30-Month Stays, and ANDAs and 505(b)(2) 
Applications Under Hatch-Waxman, as Amended by the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003--
Questions and Answers''--issued November 2004.
21. ``Referencing Discontinued Labeling for Listed Drugs in Abbreviated 
New Drug Applications''--issued October 2000.
22. ``Submission of Patent Information for Certain Old Antibiotics''--
issued December 2008.

    For information on the preceding four guidances (number 19 through 
22), contact the Office of Pharmaceutical Science in CDER.

23. ``Qualifying for Pediatric Exclusivity Under Section 505A of the 
Federal Food, Drug, and Cosmetic Act''--issued September 1999.

    For information on the preceding guidance (number 23), contact the 
Pediatric and Maternal Health Staff in the Office of New Drugs in CDER.

III. Revision or Finalization of Guidances

    In addition to identifying the first set of guidances for 
withdrawal, CDER also identified guidances for revision or 
finalization. CDER is in the process of developing a plan for their 
completion. Guidances for revision or finalization are specific to the 
following topics:
     Biopharmaceutics;
     Chemistry, manufacturing, and controls;
     Clinical pharmacology;
     Combination products;
     cGMP compliance;
     Development of antimicrobial drugs;
     Drug advertisements;
     Drug safety;
     Electronic submissions;
     Labeling;
     OTC products;
     Pharmacology and toxicology;
     Procedural guidances; and
     Radiopharmaceuticals.

IV. Maintaining Transparency

    CDER would like to make this process as transparent as possible, 
consistent with the GGP regulation. As a result, CDER is issuing this 
notice announcing the initiative for draft guidance review, and listing 
the first group of guidances for withdrawal. CDER also maintains and 
regularly updates on its guidance Web site a list of new, revised, and 
withdrawn guidances (at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm). Each 
year CDER also publishes on its guidance Web site a Guidance Agenda, 
which lists new draft and revised draft guidances planned for issuance 
in the given calendar year.

V. Comments

    Interested persons may submit either electronic comments regarding 
Agency guidance documents to http://www.regulations.gov or written 
comments to the Division of Dockets Management (see ADDRESSES). It is 
only necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain CDER guidance 
documents at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.


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    Dated: August 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19051 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P


