Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671), 3910-3912 [2011-1270]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with NOTICES 3910 Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices contact Rory Howe at 410–786–4878. For all other issues call 410–786–1326.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Disproportionate Share Hospital Annual Reporting; Use: Section 1923(j)(i) of the Social Security Act requires States to submit an annual report that identifies each disproportionate share hospital (DSH) that received a DSH payment under the State’s Medicaid program in the preceding fiscal year and the amount of DSH payments paid to that hospital in the same year and such other information as the Secretary determines necessary to ensure the appropriateness of DSH payments. The information supplied will also satisfy the requirements under section 1923(a)(2)(D) of the Act; Form Number: CMS–R–266 (OMB#: 0938–0746); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 52; Total Annual Responses: 52; Total Annual Hours: 1,976. (For policy questions regarding this collection contact Rory Howe at 410–786–4878. For all other issues call 410–786–1326.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Organ Procurement Organization/ Histocompatibility Laboratory Statement of Reimbursable Costs, manual instructions and supporting regulations contained in 42 CFR 413.20 and 413.24; Use: This form is required by the statute and regulation for participation in the Medicare program. The information is used to determine payment for Medicare. Organ Procurement Organizations and Histocompatibility Laboratories are the users. Form Number: CMS–216–94 (OMB# 0938–0102); Frequency: Yearly; Affected Public: Business or other forprofit, not-for-profit institutions; Number of Respondents: 115; Total Annual Responses: 115; Total Annual Hours: 5,175. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web site at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control VerDate Mar<15>2010 13:45 Jan 20, 2011 Jkt 223001 number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by March 22, 2011: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2011–1265 Filed 1–20–11; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0015] Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/ Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671). SUMMARY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Submit either electronic or written comments on the collection of information by March 22, 2011. DATES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850. 301–796– 3794. Jonnalynn.Capezzuto@ fda.hhs.gov. Under 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, including each proposed extension of an existing 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 in this document. With respect to the following collection of information, FDA invites comments on these topics: (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 of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: E:\FR\FM\21JAN1.SGM 21JAN1 3911 Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671)—21 CFR Part 316 (OMB Control Number 0910–0167)—Extension Sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory authority to do the following: (1) Provide recommendations on investigations required for approval of marketing applications for orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and (4) encourage sponsors to make orphan drugs available for treatment on an ‘‘open protocol’’ basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the FD&C Act and sets forth procedures FDA will use in administering the FD&C Act with regard to orphan drugs. Section 316.10 specifies the content and format of a request for written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Based on past experience, FDA estimates that there will be two respondents to §§ 316.10, 316.12, and 316.14 requiring 200 hours of human resources annually. Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.21 specifies content of a request for orphan drug designation required for verification of orphan-drug status. Section 316.26 allows an applicant to amend the applications under certain circumstances. The Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671) is intended to benefit sponsors who desire to seek orphan designation of drugs intended for rare diseases or conditions from both the European Commission and FDA by reducing the burden of preparing separate applications to meet the regulatory requirements in each jurisdiction. It highlights the regulatory cooperation between the United States (U.S.) and the European Union (EU) mandated by the Transatlantic Economic Council (TEC). FDA does not believe the new form will result in any increased burden on the respondents and therefore we estimate no additional burden. Based on past experience, FDA estimates there will be 214 respondents requiring 64,200 hours of human resources annually. Section 316.22 specifies requirement of a permanent resident agent for foreign sponsors. Based on past experience, FDA estimates 55 respondents requiring 110 hours of human resources annually. Section 316.27 specifies content of a change in ownership of orphan-drug designation. Based on past experience, FDA estimates 43 respondents requiring 215 hours of human resources annually. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. Based on number of orphan-drug designations, the number of respondents is estimated as 1,652 requiring 4,956 hours of human resources annually. Finally, § 316.36 describes information required of sponsor when there is insufficient quantity of approved orphan drug. Based on past experience, FDA estimates one respondent requiring 45 hours of human resources annually. The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining orphan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents 21 CFR Section and FDA Form Annual frequency per response Total annual responses Hours per response Total hours 316.10, 316.12, and 316.14 ............................. 316.20, 316.21, and 316.26; Form FDA 3671 316.22 .............................................................. 316.27 .............................................................. 316.30 .............................................................. 316.36 .............................................................. 2 214 55 43 1,652 1 1 2 1 1 1 3 2 428 55 43 1,652 3 100 150 2 5 3 15 200 64,200 110 215 4,956 45 Total .......................................................... ............................ ............................ ............................ ............................ 69,726 WReier-Aviles on DSKGBLS3C1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 13:45 Jan 20, 2011 Jkt 223001 PO 00000 Frm 00036 Fmt 4703 Sfmt 9990 E:\FR\FM\21JAN1.SGM 21JAN1 3912 Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices Dated: January 18, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–1270 Filed 1–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. WReier-Aviles on DSKGBLS3C1PROD with NOTICES 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: Peripheral and Central Nervous System Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 10, 2011, from 8 a.m. to 5 p.m. Location: Hilton Washington DC/ Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589– 5200. Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31–2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301– 847–8533, e-mail: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. 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 March 10, 2011, the committee will discuss, in general, the use of historical-controlled trials for the VerDate Mar<15>2010 13:45 Jan 20, 2011 Jkt 223001 approval of anticonvulsant monotherapy for seizures of partial origin for antiepileptic drug products that are already approved for adjunctive therapy. The committee will also discuss how this may specifically apply to the approval of the supplemental new drug application 022115/S–011, LAMICTAL XR (lamotrigine extendedrelease tablets), sponsored by SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug. 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. 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 February 24, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 February 15, 2011. 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 February 16, 2011. 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 a disability, please contact Diem-Kieu Ngo 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 https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.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: January 18, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–1264 Filed 1–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; 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: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 2, 2011, from 7:15 a.m. to 3 p.m. Location: Hyatt Regency Dallas at Reunion, Landmark Ballroom, 300 Reunion Blvd., Dallas, TX 75207. The hotel phone number is 214–651–1234. Contact Person: Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847– 8540, e-mail: yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), and follow prompts to the desired center or product area. 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 E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Pages 3910-3912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1270]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0015]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Orphan Drugs; Common European Medicines Agency/Food 
and Drug Administration Application Form for Orphan Medicinal Product 
Designation (Form FDA 3671)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the procedures by which 
sponsors of orphan drugs may request eligibility for the incentives by 
implementing a program as outlined in the Orphan Drug Act and the joint 
adoption by FDA and the European Medicines Agency (EMA) of the Common 
EMA/FDA Application Form for Orphan Medicinal Product Designation (form 
FDA 3671).

DATES: Submit either electronic or written comments on the collection 
of information by March 22, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850. 301-796-3794. Jonnalynn.Capezzuto@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing 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 in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 3911]]

Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal 
Product Designation (Form FDA 3671)--21 CFR Part 316 (OMB Control 
Number 0910-0167)--Extension

    Sections 525 through 528 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory 
authority to do the following: (1) Provide recommendations on 
investigations required for approval of marketing applications for 
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set 
forth conditions under which a sponsor of an approved orphan drug 
obtains exclusive approval, and (4) encourage sponsors to make orphan 
drugs available for treatment on an ``open protocol'' basis before the 
drug has been approved for general marketing. The implementing 
regulations for these statutory requirements have been codified under 
part 316 (21 CFR part 316) and specify procedures that sponsors of 
orphan drugs use in availing themselves of the incentives provided for 
orphan drugs in the FD&C Act and sets forth procedures FDA will use in 
administering the FD&C Act with regard to orphan drugs. Section 316.10 
specifies the content and format of a request for written 
recommendations concerning the non-clinical laboratory studies and 
clinical investigations necessary for approval of marketing 
applications. Section 316.12 provides that, before providing such 
recommendations, FDA may require results of studies to be submitted for 
review. Section 316.14 contains provisions permitting FDA to refuse to 
provide written recommendations under certain circumstances. Within 90 
days of any refusal, a sponsor may submit additional information 
specified by FDA. Based on past experience, FDA estimates that there 
will be two respondents to Sec. Sec.  316.10, 316.12, and 316.14 
requiring 200 hours of human resources annually.
    Section 316.20 specifies the content and format of an orphan drug 
application which includes requirements that an applicant document that 
the disease is rare (affects fewer than 200,000 persons in the United 
States annually) or that the sponsor of the drug has no reasonable 
expectation of recovering costs of research and development of the 
drug. Section 316.21 specifies content of a request for orphan drug 
designation required for verification of orphan-drug status. Section 
316.26 allows an applicant to amend the applications under certain 
circumstances. The Common EMA/FDA Application Form for Orphan Medicinal 
Product Designation (form FDA 3671) is intended to benefit sponsors who 
desire to seek orphan designation of drugs intended for rare diseases 
or conditions from both the European Commission and FDA by reducing the 
burden of preparing separate applications to meet the regulatory 
requirements in each jurisdiction. It highlights the regulatory 
cooperation between the United States (U.S.) and the European Union 
(EU) mandated by the Transatlantic Economic Council (TEC). FDA does not 
believe the new form will result in any increased burden on the 
respondents and therefore we estimate no additional burden. Based on 
past experience, FDA estimates there will be 214 respondents requiring 
64,200 hours of human resources annually. Section 316.22 specifies 
requirement of a permanent resident agent for foreign sponsors. Based 
on past experience, FDA estimates 55 respondents requiring 110 hours of 
human resources annually. Section 316.27 specifies content of a change 
in ownership of orphan-drug designation. Based on past experience, FDA 
estimates 43 respondents requiring 215 hours of human resources 
annually. Section 316.30 requires submission of annual reports, 
including progress reports on studies, a description of the 
investigational plan, and a discussion of changes that may affect 
orphan status. Based on number of orphan-drug designations, the number 
of respondents is estimated as 1,652 requiring 4,956 hours of human 
resources annually. Finally, Sec.  316.36 describes information 
required of sponsor when there is insufficient quantity of approved 
orphan drug. Based on past experience, FDA estimates one respondent 
requiring 45 hours of human resources annually.
    The information requested will provide the basis for an FDA 
determination that the drug is for a rare disease or condition and 
satisfies the requirements for obtaining orphan drug status. Secondly, 
the information will describe the medical and regulatory history of the 
drug. The respondents to this collection of information are 
biotechnology firms, drug companies, and academic clinical researchers.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of     Annual frequency    Total annual        Hours per
                  21 CFR Section and FDA Form                      respondents      per response        responses         response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14....................................                 2                 1                 2               100               200
316.20, 316.21, and 316.26; Form FDA 3671.....................               214                 2               428               150            64,200
316.22........................................................                55                 1                55                 2               110
316.27........................................................                43                 1                43                 5               215
316.30........................................................             1,652                 1             1,652                 3             4,956
316.36........................................................                 1                 3                 3                15                45
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................            69,726
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 3912]]

    Dated: January 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1270 Filed 1-20-11; 8:45 am]
BILLING CODE 4160-01-P
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