Notices. Notice

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0098] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 14, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0497. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Focus Groups as Used by the Food and Drug Administration—(OMB Control Number 0910-0497)—Extension Focus groups provide an important role in gathering information because they allow for a more in-depth understanding of consumers' attitudes, beliefs, motivations, and feelings than do quantitative studies. Focus groups serve the narrowly defined need for direct and informal opinion on a specific topic and as a qualitative research tool have three major purposes: • To obtain consumer information that is useful for developing variables and measures for quantitative studies, • To better understand consumers' attitudes and emotions in response to topics and concepts, and • To further explore findings obtained from quantitative studies. FDA will use focus group findings to test and refine their ideas, but will generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. In the **Federal Register** of March 27, 2007 (72 FR 14279), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden for completing the forms for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Center Subject No. of Focus Groups per Study No. of Focus Groups Sessions Conducted Annually No. of Participants per Group Hours of Duration for Each Group (Includes Screening) Total Hours Center for Biologics Evaluation and Research May use focus groups when appropriate 1 5 9 1.58 71 Center for Drug Evaluation and Research Varies (e.g., direct-to-consumer Rx drug promotion, physician labeling of Rx drugs, medication guides, over-the-counter drug labeling, risk communication) 10 200 9 1.58 2,844 Center for Devices and Radiological Health Varies (e.g., FDA Seal of Approval, patient labeling, tampons, online sales of medical products, latex gloves) 4 16 9 2.08 300 Center for Food Safety and Applied Nutrition Varies (e.g., food safety, nutrition, dietary supplements, and consumer education) 8 40 9 1.58 569 Center for Veterinary Medicine Varies (e.g., animal nutrition, supplements, labeling of animal Rx) 5 25 9 2.08 468 Total 28 286 9 1.78 4,252 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Annually, FDA projects about 28 focus group studies using 186 focus groups lasting an average of 1.78 hours each. FDA has allowed burden for unplanned focus groups to be completed so as not to restrict the agency's ability to gather information on public sentiment for its proposals in its regulatory as well as other programs. Dated: October 9, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20291 Filed 10-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pediatric Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services, when that research is also regulated by FDA. *Date and Time* : The meeting will be held on Tuesday, November 27, 2007, from 8 a.m. to 5:30 p.m. and Wednesday, November 28, 2007, from 8 a.m. to 6 p.m. *Location* : Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Carlos Peña, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), Rockville, MD 20857, 301-827-3340, e-mail: *Carlos.Peña@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up to date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On November 27, 2007, in response to the Pediatric Advisory Committee's 2005 request for specific updates after 2 additional years of influenza seasons, the committee will receive information on adverse event reports, focusing on neuropsychiatric and behavioral events, for Tamiflu (OSELTAMIVIR). On November 28, 2007, the Pediatric Advisory Committee will hear and discuss reports by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports for Serevent (SALMETEROL), Provigil (MODAFINIL), Azopt (BRINZOLAMIDE), Bextaxon (LEVOBETAXOLOL), Emtrivia (EMTRICITABINE), and Gleevec (IMATINAB MESYLATE). The Pediatric Advisory Committee will also hear about and discuss the Pediatric Initiatives between FDA and the European Medicines Agency. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 5, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2: p.m. on November 27, 2007 and 11 a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on November 28, 2007. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 26, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 29, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Dr. Carlos Peña at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 8, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-20302 Filed 10-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pediatric Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services , when that research is also regulated by FDA. *Date and Time* : The meeting will be held on Thursday, November 29, 2007, from 8 a.m. to 4 p.m. *Location* : Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Carlos Peña, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), Rockville, MD 20857, 301-827-3340, e-mail: *Carlos.Peña@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The Pediatric Advisory Committee will hear and discuss issues related to FDA's draft guidance for Industry entitled “Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling,” that published in the **Federal Register** of Tuesday, February 8, 2005 (70 FR 6697). As part of the review and consideration of public comments received by FDA in response to this draft guidance, the Pediatric Advisory Committee will hear and discuss information on: Labeling of drugs for use by lactating women; breastfeeding physiology, benefits, and current research; the physiology and pharmacology of drug transfer into breast milk; and ethical issues related to studying breastfeeding mother/infant pairs. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material will be available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 5, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. to 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 26, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 29, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Dr. Carlos Peña at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 8, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-20304 Filed 10-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0367] Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance for industry entitled “Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval.” The purpose of this guidance is to inform industry of FDA's current thinking regarding appropriate clinical study designs to evaluate antibacterial drugs, and to ask sponsors to amend ongoing or completed studies accordingly. This guidance is in response to a number of public discussions in recent years regarding the use of active-controlled studies designed to show noninferiority as a basis for approval of antibacterial drug products. 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 December 14, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), 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 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 *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Edward Cox, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6412, Silver Spring, MD 20993-0002, 301-796-1300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval.” Most antibacterial drugs have been approved based on active-controlled noninferiority trials. There have been a number of public discussions in recent years on the use of noninferiority studies to support regulatory approval of antibacterial drug products. Some of these discussions have focused on specific diseases such as acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. These public discussions have contributed to FDA's evolving understanding of the science of clinical trials and, in particular, the appropriate role of active-controlled studies designed to show noninferiority in the development of antibacterial drug products. This draft guidance recommends that sponsors provide justification for the treatment effect size and the proposed noninferiority margin for all antibacterial development programs for which approval will rely on noninferiority studies. 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 use of noninferiority studies to support approval of antibacterial drug products. 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively, and the collection of information under the guidance for industry Special Protocol Assessment has been approved under OMB control number 0910-0470. III. 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. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: October 9, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-20282 Filed 10-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0388] Draft Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” This draft guidance is intended to assist the dietary supplement industry in complying with the serious adverse events reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Separate guidance, issued by the Center for Drug Evaluation and Research on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the **Federal Register** . DATES: Submit written or electronic comments on the draft guidance document, including comments regarding proposed collection of information, by December 14, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist the office in processing your request, or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit written comments on the draft guidance, including comments regarding proposed collection of information, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Vasilios Frankos, Center for Food Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled “Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) (Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and Cosmetic Act (the act) with respect to serious adverse event reporting for dietary supplements and non-prescription drugs marketed without an approved application. The draft guidance document contains questions and answers relating to the new requirements under the DSNDCPA, concerning the mandatory reporting to FDA of serious adverse events associated with dietary supplements, the minimum data elements to be submitted in such reports, and records of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA'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 requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth below. With respect to the following collection of information, FDA invites comment on:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. *Title* : Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. *Description of Respondents* : Respondents to this collection of information are manufacturers, packers, and distributors of dietary supplements marketed in the United States. The draft guidance presents FDA's recommendations for complying with the dietary supplement adverse event reporting and recordkeeping requirements of the act, as amended by the DSNDCPA. These requirements become effective on December 22, 2007. A. Reporting Under section 761(b)(1) of the act (21 U.S.C. 379aa-1(b)(1)), the manufacturer, packer, or distributor whose name (under section 403(e)(1) of the act (21 U.S.C. 343(e)(1))) appears on the label of a dietary supplement marketed in the United States is required to submit to FDA any serious adverse event report it receives regarding use of the dietary supplement in the United States, accompanied by a copy of the product label. In addition, under section 761(c)(2) of the act, the submitter of the serious adverse event report (referred to in the statute as the “responsible person”) is required to submit to FDA a followup report of any related new medical information the responsible person receives within 1 year of the initial report. The draft guidance discusses how, when, and where to submit serious adverse event reports for dietary supplements and followup reports of new medical information. In accordance with the statutory requirements that serious adverse event reports for dietary supplements be submitted via MedWatch (section 761(d) of the act) and that FDA consolidate all information related to a serious adverse event into a single report (section 761(c)(3) of the act), the draft guidance directs the responsible person to submit serious adverse event reports on MedWatch Form 3500A and to attach a copy of the initial serious adverse event report on Form 3500A as part of any followup report of new medical information. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of respondents Annual frequency per response Total annual responses Hours per response Total hours Serious adverse event reports for dietary supplements (21 U.S.C. 379aa-1(b)(1)) 80 12 960 2 1,920 Followup reports of new medical information (21 U.S.C. 379aa-1(c)(2)) 20 12 240 1 420 Total 2,160 1 There are no capital costs or operating and maintenance costs associated with this collection of information. B. Reporting Burden Because mandatory reporting of serious adverse events for dietary supplements does not become effective until December 22, 2007, FDA has no data on mandatory dietary supplement adverse event reports from past years to use in developing a burden estimate. However, FDA currently collects voluntarily-submitted adverse event reports for dietary supplements. Industry, health care providers, and consumers voluntarily submit several thousand reports annually to FDA's Center for Food Safety and Applied Nutrition (CFSAN) through the CFSAN Adverse Events Reporting System (CAERS), which contains reports of adverse events associated with conventional foods, dietary supplements, and cosmetics. According to a Congressional Budget Office Cost Estimate (Ref. 1), in 2005 CAERS received almost 500 reports of adverse events suspected to be related to dietary supplements. Only manufacturers, packers, and distributors of dietary supplements are required to report adverse events for these products to FDA, and only if the firm's name appears on the label of the dietary supplement associated with the adverse event. Moreover, reporting is required only for those adverse events defined as “serious.” FDA does not know how many of the 500 reports of dietary supplement adverse events voluntarily submitted in 2005 would have been considered serious, nor how many of these reports originated from or were reported to the manufacturer, packer, or distributor whose name appears on the label of the dietary supplement associated with the adverse event. As a rough estimate for planning purposes, CAERS staff estimate that they will receive about 80 serious adverse event reports relating to dietary supplements each month. Thus, we estimate that the number of dietary supplement serious adverse event reports submitted to FDA annually will total 960 reports (12 x 80 reports per month). FDA requests comments on this estimate. FDA's Center for Drug Evaluation and Research estimates it will take respondents a total of 2 hours to collect information about a serious adverse event associated with an over-the-counter drug marketed without an approved application and report the information to FDA on MedWatch Form 3500A. That time burden estimate is based on FDA's knowledge of the adverse drug experience reports submitted to the agency for nonprescription drug products marketed under an approved application, including knowledge about the time needed to prepare the reports. FDA believes that the time for a dietary supplement firm to collect information about a serious adverse event associated with a dietary supplement and report the information to FDA will be approximately the same, as MedWatch Form 3500A will be used in both cases; therefore, we also estimate this time burden at 2 hours per report. The estimated total annual burden for dietary supplement serious adverse event reports is shown in row 1 of table 1 of this document. If a firm that has submitted a serious adverse event report receives new medical information related to the serious adverse event within 1 year of submitting the initial report, the firm must provide the new medical information to FDA in a followup report. Given our lack of experience with mandatory dietary supplement adverse event reporting, we do not have any information on the number of followup reports of new medical information that will be submitted to FDA each year. We expect followup medical information to be reported for some percentage of the 960 serious adverse event reports we estimate receiving annually. In the absence of data that would support a more precise estimate, we will assume that 25 percent of the 960 serious adverse event reports for dietary supplements will have a followup report submitted. FDA requests comments on this estimate. We estimate that each followup report will require an hour to assemble and submit, including the time needed to copy and attach the initial serious adverse event report as recommended in the draft guidance. We assume the followup report will take less time than the initial serious adverse event report, as the responsible person will not need to fill out Form 3500A for the followup report. FDA requests comments on whether the burden estimate of 1 hour is reasonable for this information collection. The estimated total annual burden for followup reports of new medical information is shown in row 2 of table 1 of this document. C. Recordkeeping Section 761(e)(1) of the act requires that responsible persons maintain records related to dietary supplement adverse event reports they receive, whether or not the adverse event is serious. Under the statute, the records must be retained for a period of 6 years. The draft guidance provides FDA's recommendations as to what records industry should maintain to satisfy the statutory recordkeeping requirement. The guidance recommends that the responsible person document its attempts to obtain the minimum data elements for a serious adverse event report. Along with these records, the guidance recommends that the responsible person keep the following other records:

(1)Communications between the responsible person and the initial reporter of the adverse event and with any other person(s) who provided information about the adverse event;

(2)(for serious adverse events only) the responsible person's serious adverse event report to FDA on MedWatch Form 3500A, with attachments;

(3)any new medical information about the adverse event received by the responsible person;

(4)(for serious adverse events only) any reports to FDA of new medical information related to the serious adverse event report. We estimate that assembling and filing these records, including any necessary photocopying, will take approximately 0.5 hours per adverse event report received by the responsible person. Once the documents pertaining to an adverse event report have been assembled and filed, FDA expects the records retention burden to be minimal, as the agency believes most establishments would normally keep this kind of record for at least several years after receiving the report, as a matter of usual and customary business practice. FDA requests comment on current adverse event recordkeeping practices in the dietary supplement industry, including the length of time such records are typically kept. According to a 2001 report by the Office of the Inspector General, between 1994-1999 FDA received 2,547 adverse event reports involving dietary supplements, or about 500 reports per year, on average (Ref. 2). According to the report, the actual number of adverse events relating to dietary supplements is likely to be at least 100 times that many, or more than 50,000 adverse events per year. In the absence of data on how many adverse events will be reported each year to the responsible person once the DSNDCPA becomes effective in December 1997, we are using the 50,000 per year figure as an upper bound estimate of reporting. This is almost certainly an overestimate of the number of reports the firms will receive, as it is unlikely that every adverse event that occurs will be reported to the responsible person. FDA requests comments on this estimate. We estimated in the economic impact analysis of the Dietary Supplement Good Manufacturing Practices final rule (the GMP final rule) (72 FR 34752, June 25, 2007) that there are 1,460 manufacturers, packers, and holders of dietary supplements (72 FR 34752 at 34920). We assume that the estimated 50,000 adverse event reports related to dietary supplements will be spread evenly among these firms. The estimate of the number of manufacturers, packers, and holders of dietary supplements from the GMP final rule is FDA's best estimate of the number of firms that are “responsible persons” who must comply with the recordkeeping requirements of the DSNDCPA; however, it is not a precise estimate because the number of dietary supplement establishments covered by the GMP final rule is likely to be larger than the number of “responsible persons,” where a “responsible person” is a dietary supplement manufacturer, packer, or distributor whose name is listed on the label of a dietary supplement marketed in the United States (see section 761(b)(1) of the act). Thus, FDA's estimate for the number of respondents in table 2 may be overinclusive. FDA requests comments on the number of firms that would be subject to the recordkeeping requirements of the DSNDCPA. The estimated total annual recordkeeping burden under the statute and this guidance is shown in table 2 of this document. **Table 2.—Estimated Annual Recordkeeping Burden** 1 No. of recordkeepers Annual frequency per recordkeeping Total annual records 2 Hours per record Total hours Dietary supplement adverse event records (21 U.S.C. 379aa-1(e)(1)) 1,460 4.2465 50,000 0.5 25,000 Total 25,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 For purposes of estimating the number of records and hours per record, a “record” means all records kept for an individual adverse event report received by the responsible person. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance, including comments regarding proposed collection of information. 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. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. S. 3546 Dietary Supplement and Nonprescription Drug and Consumer Protection Act, Congressional Budget Office Cost Estimate, December 27, 2006. 2. “Adverse Event Reporting For Dietary Supplements: An Inadequate Safety Valve,” Office of the Inspector General, Department of Health and Human Services, April 2001, OEI-01-00-00180. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at *http://www.cfsan.fda.gov/guidance.html* . Dated: October 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-5074 Filed 10-11-07; 11:34 am]

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