Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability, 52242-52243 [E9-24435]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES 52242 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product ENTEREG (alvimopan). ENTEREG is a peripherally acting μ-opioid receptor antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for ENTEREG (U.S. Patent Nos. 5,250,542 and 5,434,171) from Eli Lilly and Company, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 26, 2009, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of ENTEREG represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for ENTEREG is 5,305 days. Of this time, 3,879 days occurred during the testing phase of the regulatory review period, while 1,426 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: November 12, 1993. The applicant claims November 11, 1993, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 12, 1993, which was 30 days after FDA receipt of the IND. VerDate Nov<24>2008 16:05 Oct 08, 2009 Jkt 220001 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: June 25, 2004. FDA has verified the applicant’s claim that the new drug application (NDA) 21–775 was submitted on June 25, 2004. 3. The date the application was approved: May 20, 2008. FDA has verified the applicant’s claim that NDA 21–775 was approved on May 20, 2008. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,827 days of patent term extension for U.S. Patent No. 5,250,542 and 1,826 days of patent term extension for U.S. Patent No. 5,434,171. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by December 8, 2009. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by April 7, 2010. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information 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. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: August 31, 2009. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E9–24457 Filed 10–8–09; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0448] Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.’’ This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA’s current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). This guidance document updates previous guidance. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 7, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. Identify comments with the docket number E:\FR\FM\09OCN1.SGM 09OCN1 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Charles Finder, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993–0002, 301–796–5715. SUPPLEMENTARY INFORMATION: mstockstill on DSKH9S0YB1PROD with NOTICES I. Background MQSA (Pub. L. 102–539) was signed into law on October 27, 1992, to establish national quality standards for mammography. It is codified at 42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide mammography services after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or by an approved State certification agency (section 354(b) of the MQSA; 42 U.S.C. 263b(b)). In June 1993, the authority to approve accreditation bodies and State certification agencies and to certify facilities was delegated by the Secretary to the FDA (58 FR 32543). On October 28, 1997, the FDA first published final regulations implementing the MQSA in the Federal Register (21 CFR part 900) (62 FR 55852). The MQSA has twice been amended since its enactment, through the Mammography Quality Standards Reauthorization Acts (MQSRA) of 1998 and 2004 (Pub. L. 105–248 and Pub. L. 108–365). This draft guidance updates the Policy Guidance Help System and addresses or contains the following: 1. Updated contact information for accreditation bodies and certification agencies; 2. General guidance regarding Additional Mammography Reviews (AMRs); 3. Previously approved alternative standards; 4. Centers for Medicare and Medicaid Services (CMS) reimbursement; 5. Mechanisms to inform physicians and patients of mammography results; 6. Labeling of mammographic images; 7. Mammographic modality and its impact on personnel experience requirements; 8. Clarification of the personnel 6month exemption period; 9. Information on calibrating the air kerma measuring instrument; 10. Medical physicist involvement as it applies to cassette replacement; 11. Full Field Digital Mammography (FFDM) and use of single-use cushion pads; VerDate Nov<24>2008 16:05 Oct 08, 2009 Jkt 220001 12. Quality control testing of computer controlled compression devices; 13. Mammography equipment evaluations of laser printers; 14. Quality control testing of monitors and laser printers; 15. Mammography equipment evaluations of new FFDM units; and 16. Mammography equipment evaluations of off-site laser printers and monitors. In November 1998, FDA compiled all to-date final FDA guidances related to MQSA and put them into a computerized searchable database called the Policy Guidance Help System (PGHS). The PGHS is available on the Internet at https://www.fda.gov/cdrh/ mammography/robohelp/start.htm. FDA periodically updates the information in the PGHS, and this document serves as a further update. Individuals wishing to receive automatic notification of future updates may subscribe to our e-mail ListServ by visiting https://service.govdelivery.com/ service/subscribe.html?code=USFDA_45 and following the directions there. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on ‘‘The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13.’’ 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive ‘‘The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number (1695) to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 52243 Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturers’ assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available at https://www.regulations.gov. IV. Paperwork Reduction Act This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 900 have been approved under OMB Control No. 0910–0309. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 1, 2009. Jeffrey Shuren, Acting Director, Center for Devices and Radiological Health. [FR Doc. E9–24435 Filed 10–8–09; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Pages 52242-52243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24435]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0448]


Draft Guidance for Industry and Food and Drug Administration 
Staff; the Mammography Quality Standards Act Final Regulations: 
Modifications and Additions to Policy Guidance Help System 13; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``The Mammography Quality 
Standards Act Final Regulations: Modifications and Additions to Policy 
Guidance Help System 13.'' This document is intended to 
provide guidance to mammography facilities and their personnel. It 
represents FDA's current thinking on the final regulations implementing 
the Mammography Quality Standards Act of 1992 (MQSA). This guidance 
document updates previous guidance. This draft guidance is not final 
nor is it in effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by January 7, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``The Mammography Quality Standards Act 
Final Regulations: Modifications and Additions to Policy Guidance Help 
System 13'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to https://www.regulations.gov. Identify comments with the 
docket number

[[Page 52243]]

found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Charles Finder, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 4646, Silver Spring, MD 20993-0002, 301-
796-5715.

SUPPLEMENTARY INFORMATION:

I. Background

    MQSA (Pub. L. 102-539) was signed into law on October 27, 1992, to 
establish national quality standards for mammography. It is codified at 
42 U.S.C. 263b. The MQSA requires that, in order to lawfully provide 
mammography services after October 1, 1994, all facilities, except 
facilities of the Department of Veterans Affairs, must be accredited by 
an approved accreditation body and certified by the Secretary of Health 
and Human Services (the Secretary) or by an approved State 
certification agency (section 354(b) of the MQSA; 42 U.S.C. 263b(b)). 
In June 1993, the authority to approve accreditation bodies and State 
certification agencies and to certify facilities was delegated by the 
Secretary to the FDA (58 FR 32543). On October 28, 1997, the FDA first 
published final regulations implementing the MQSA in the Federal 
Register (21 CFR part 900) (62 FR 55852). The MQSA has twice been 
amended since its enactment, through the Mammography Quality Standards 
Reauthorization Acts (MQSRA) of 1998 and 2004 (Pub. L. 105-248 and Pub. 
L. 108-365).
    This draft guidance updates the Policy Guidance Help System and 
addresses or contains the following:
    1. Updated contact information for accreditation bodies and 
certification agencies;
    2. General guidance regarding Additional Mammography Reviews 
(AMRs);
    3. Previously approved alternative standards;
    4. Centers for Medicare and Medicaid Services (CMS) reimbursement;
    5. Mechanisms to inform physicians and patients of mammography 
results;
    6. Labeling of mammographic images;
    7. Mammographic modality and its impact on personnel experience 
requirements;
    8. Clarification of the personnel 6-month exemption period;
    9. Information on calibrating the air kerma measuring instrument;
    10. Medical physicist involvement as it applies to cassette 
replacement;
    11. Full Field Digital Mammography (FFDM) and use of single-use 
cushion pads;
    12. Quality control testing of computer controlled compression 
devices;
    13. Mammography equipment evaluations of laser printers;
    14. Quality control testing of monitors and laser printers;
    15. Mammography equipment evaluations of new FFDM units; and
    16. Mammography equipment evaluations of off-site laser printers 
and monitors.
    In November 1998, FDA compiled all to-date final FDA guidances 
related to MQSA and put them into a computerized searchable database 
called the Policy Guidance Help System (PGHS). The PGHS is available on 
the Internet at https://www.fda.gov/cdrh/mammography/robohelp/start.htm.
    FDA periodically updates the information in the PGHS, and this 
document serves as a further update. Individuals wishing to receive 
automatic notification of future updates may subscribe to our e-mail 
ListServ by visiting https://service.govdelivery.com/service/subscribe.html?code=USFDA_45 and following the directions there.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on ``The 
Mammography Quality Standards Act Final Regulations: Modifications and 
Additions to Policy Guidance Help System 13.'' 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 statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``The Mammography Quality 
Standards Act Final Regulations: Modifications and Additions to Policy 
Guidance Help System 13,'' you may either send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number (1695) to identify the guidance you are 
requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at https://www.regulations.gov.

IV. Paperwork Reduction Act

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 900 have been approved under 
OMB Control No. 0910-0309.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper 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 Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 1, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24435 Filed 10-8-09; 8:45 am]
BILLING CODE 4160-01-S
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