International Conference on Harmonisation; Addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability, 29665-29666 [2012-12039]

Download as PDF Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–P–0604] Determination That PITRESSIN TANNATE IN OIL (Vasopressin Tannate) Injection, 5 Pressor Units/ Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for vasopressin tannate injection, 5 pressor units/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Molly Flannery, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6246, Silver Spring, MD 20993–0002, 301– 796–3543. 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 under an ANDA procedure. ANDA applicants 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. ANDA applicants 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 Cosmetic Act (21 U.S.C. 355(j)(7)), 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 known generally as the mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:21 May 17, 2012 Jkt 226001 ‘‘Orange Book.’’ Under FDA regulations, drugs are removed 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). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, is the subject of NDA 03–402, held by Parke-Davis Pharmaceutical Research (Parke-Davis). PITRESSIN TANNATE IN OIL is indicated for the control or prevention of the symptoms and complications of diabetes insipidus due to a deficiency of endogenous posterior pituitary antidiuretic hormone. In a letter dated April 23, 1993, ParkeDavis requested the withdrawal of NDA 03–402 for PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL. In the Federal Register of September 25, 1998 (63 FR 51359), FDA announced that it was withdrawing approval of NDA 03–402, effective September 25, 1998. Lachman Consultant Services, Inc., submitted a citizen petition dated November 19, 2010 (Docket No. FDA– 2010–P–0604), under 21 CFR 10.30, requesting that the Agency determine whether PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, from sale. We have PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 29665 also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, 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. ANDAs that refer to PITRESSIN TANNATE IN OIL (vasopressin tannate) Injection, 5 pressor units/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: May 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–12040 Filed 5–17–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0573] International Conference on Harmonisation; Addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals’’ (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1 29666 Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES entitled ‘‘S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals’’ (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002, or the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827– 1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://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. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Anne M. Pilaro, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2324, Silver Spring, MD 20993–0002, 301–796–2320; or Mercedes A. Serabian, Center for Biologics Evaluation and Research (HFM–760), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–4119. Regarding the ICH: Michelle Limoli, Office of International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm 3506, Silver Spring, MD 20993, 301–796– 4600. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of VerDate Mar<15>2010 18:21 May 17, 2012 Jkt 226001 harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the Federal Register of December 17, 2009 (74 FR 66980), FDA published a notice announcing the availability of a draft guidance entitled ‘‘Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6)(R1).’’ The notice gave interested persons an opportunity to submit comments by February 1, 2010. After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in June 2011. The S6 addendum provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. Biotechnology-derived pharmaceuticals include protein therapeutic, diagnostic, and prophylactic products derived from cell-culture systems such as bacteria, yeast, and eukaryotic cells, including organisms produced by recombinant DNA technology. The S6 addendum incorporates new knowledge and experience gained since the implementation of the ICH S6 guidance PO 00000 Frm 00079 Fmt 4703 Sfmt 9990 in 1997 and provides clarification of and greater detail to the nonclinical recommendations in ICH S6 to enable the development of safe and effective biopharmaceuticals. The S6 addendum is intended to be used in conjunction with the original ICH S6 guidance. In general, the S6 addendum is complementary to ICH S6, and where the S6 addendum differs from ICH S6, the guidance in the S6 addendum prevails. In addition, the S6 addendum harmonizes approaches given in both ICH S6 and the ICH guidance ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals’’ This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. 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. III. Electronic Access Persons with access to the Internet may obtain the document at https://www. regulations.gov, https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm. Dated: May 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–12039 Filed 5–17–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29665-29666]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12039]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0573]

International Conference on Harmonisation; Addendum to
International Conference on Harmonisation Guidance on S6 Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``S6 Addendum to Preclinical Safety
Evaluation of Biotechnology-Derived Pharmaceuticals'' (S6 addendum).
The S6 addendum was prepared under the auspices of the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to
incorporate new knowledge and experience gained since the
implementation of the ICH guidance

[[Page 29666]]

entitled ``S6 Preclinical Safety Evaluation of Biotechnology-Derived
Pharmaceuticals'' (ICH S6) and to clarify and provide greater detail to
enable the development of safe and effective biopharmaceuticals.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist the office in processing your requests. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit electronic comments on the guidance to https://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.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Anne M.
Pilaro, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2324, Silver
Spring, MD 20993-0002, 301-796-2320; or Mercedes A. Serabian, Center
for Biologics Evaluation and Research (HFM-760), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-4119.
Regarding the ICH: Michelle Limoli, Office of International Programs,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm
3506, Silver Spring, MD 20993, 301-796-4600.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of December 17, 2009 (74 FR 66980), FDA
published a notice announcing the availability of a draft guidance
entitled ``Addendum to ICH S6: Preclinical Safety Evaluation of
Biotechnology-Derived Pharmaceuticals (S6)(R1).'' The notice gave
interested persons an opportunity to submit comments by February 1,
2010.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in June 2011.
The S6 addendum provides recommendations on nonclinical studies to
support the safety of clinical trials and marketing applications for
biotechnology-derived pharmaceuticals. Biotechnology-derived
pharmaceuticals include protein therapeutic, diagnostic, and
prophylactic products derived from cell-culture systems such as
bacteria, yeast, and eukaryotic cells, including organisms produced by
recombinant DNA technology. The S6 addendum incorporates new knowledge
and experience gained since the implementation of the ICH S6 guidance
in 1997 and provides clarification of and greater detail to the
nonclinical recommendations in ICH S6 to enable the development of safe
and effective biopharmaceuticals. The S6 addendum is intended to be
used in conjunction with the original ICH S6 guidance. In general, the
S6 addendum is complementary to ICH S6, and where the S6 addendum
differs from ICH S6, the guidance in the S6 addendum prevails. In
addition, the S6 addendum harmonizes approaches given in both ICH S6
and the ICH guidance ``M3(R2) Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals''
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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.

III. Electronic Access

Persons with access to the Internet may obtain the document at
https://www.regulations.gov,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

Dated: May 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12039 Filed 5-17-12; 8:45 am]
BILLING CODE 4160-01-P

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