Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 7052-7053 [E6-1846]

Download as PDF 7052 Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices The sponsors of covered studies will be required to maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period of 2 years after the date of approval of the applications. This time is consistent with the current recordkeeping requirements for other information related to marketing applications for human drugs, biologics, and medical devices. Currently, sponsors of covered studies must maintain many records with regard to clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates than an average of 15 minutes will be required for each recordkeeper to add this record to clinical investigators’ file. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Section No. of Recordkeepers 54.6 Annual Frequency per Recordkeeping Total Annual Records 1 1,000 1,000 Hours Per Recordkeeper .25 Total are no capital costs or operating and maintenance costs associated with this collection of information. In the Federal Register of August 25, 2005 (70 FR 49928), FDA announced the availability of the draft guidance and requested comments for 60 days on the information collection. No comments were received regarding this information collection. Dated: February 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–1807 Filed 2–9–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 2005N–0425] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions AGENCY: Food and Drug Administration, HHS. 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 March 13, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written VerDate Aug<31>2005 15:10 Feb 09, 2006 Jkt 208001 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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. General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions—(OMB Control Number 0910–0183)—Extension Food and Drug Administration rmajette on PROD1PC67 with NOTICES1 250 250 1There ACTION: Total Hours The Administrative Procedures Act (5 U.S.C. 553(e)), provides that every agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Under part 10 (21 CFR part 10), § 10.30 sets forth the format and procedures by which an interested person may submit to FDA, in accordance with § 10.20 (submission of documents to the Division of Dockets Management (DDM)), a citizen petition requesting the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. Respondents are individuals or households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions or groups. Section 10.33, issued under section 701(a) of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 371(a)), sets forth the format and procedures by which an interested person may request reconsideration of part or all of a decision of the Commissioner in a petition submitted under § 10.25 (initiation of administrative proceedings). A petition for reconsideration must contain in a well-organized format a full statement of the factual and legal grounds upon which the petition relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. The respondent must submit a petition no later than 30 days after the decision has been made. However, the Commissioner may, for good cause, permit a petition to be filed after 30 days. An interested person who wishes to rely on information or views not included in the administrative record shall submit them with a new petition to modify the decision. FDA uses the information provided in the request to determine whether to grant the petition for reconsideration. Respondents to this collection of information are individuals or households, State or local governments, not-for-profit institutions, and businesses or other for-profit institutions who are requesting a reconsideration of a matter from the Commissioner. Section 10.35, issued under section 701(a) of the act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (submission of documents to DDM), the Commissioner to stay the effective date of any administrative action. Such a petition must provide the following information: (1) The decision involved; (2) the action requested, including the length of time for which a stay is requested; and (3) a statement E:\FR\FM\10FEN1.SGM 10FEN1 7053 Federal Register / Vol. 71, No. 28 / Friday, February 10, 2006 / Notices of the factual and legal grounds on which the interested person relies in seeking the stay. FDA uses the information provided in the request to determine whether to grant the petition for a stay of action. Respondents to this information collection are interested persons who choose to file a petition for an administrative stay of action. Section 10.85, issued under section 701(a) of the act, sets forth the format and procedures by which an interested person may request, in accordance with § 10.20 (submission of documents to the DDM), an advisory opinion from the Commissioner on a matter of general applicability. An advisory opinion represents the formal position of FDA on a matter of general applicability. When making a request, the petitioner must provide a concise statement of the issues and questions on which an opinion is requested, and a full statement of the facts and legal points relevant to the request. Respondents to this collection of information are interested persons seeking an advisory opinion from the Commissioner on the agency’s formal position for matters of general applicability. In the Federal Register of November 16, 2005 (70 FR 69574), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Annual Frequency per Response No. of Respondents 10.30 10.33 10.35 10.85 Total 156 10 13 2 1There 3 2 2 1 BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P–0104] Determination That PEPTAVLON (Pentagastrin) for Subcutaneous Injection, 0.25 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. rmajette on PROD1PC67 with NOTICES1 Hours per Response 468 20 26 2 Total Hours 12 10 10 16 5,616 200 260 32 6,108 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–1846 Filed 2–9–06; 8:45 am] ACTION: Total Annual Responses Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 milligrams (mg) per 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 pentagastrin for subcutaneous injection, 0.25 mg/mL. FOR FURTHER INFORMATION CONTACT: Tawni B. Schwemer, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301–594– 2041. In 1984, Congress enacted the Drug Price Competition and Patent Term SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 15:10 Feb 09, 2006 Jkt 208001 Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors 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 typically a version of the drug that was previously approved. Sponsors of ANDAs 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 generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are withdrawn 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). PEPTAVLON for subcutaneous injection is the subject of approved NDA 17–048 held by Wyeth Ayerst Laboratories (Wyeth Ayerst). PEPTAVLON (pentagastrin) for subcutaneous injection is a testing agent PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 to help diagnose problems or diseases of the stomach. This test determines how much acid a patient’s stomach produces. PEPTAVLON for subcutaneous injection, 0.25 mg/mL, was approved on July 26, 1974. Wyeth Ayerst ceased manufacture of PEPTAVLON for subcutaneous injection, 0.25 mg/mL, in March 2002, and requested that FDA withdraw approval of the NDA (68 FR 49481, August 18, 2003). Therefore, it was moved from the ‘‘Prescription Drug Product List’’ to 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. Under 21 CFR 314.161(a)(3), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness when a person petitions for such a determination under 21 CFR 10.25(a) and § 10.30 (21 CFR 10.30). Arnall Golden Gregory LLP submitted a citizen petition dated March 7, 2005 (Docket No. 2005P–0104/CP1), under § 10.30, requesting that the agency determine whether PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 mg/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that PEPTAVLON for subcutaneous injection, 0.25 mg/mL, approved under NDA 17–048, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified E:\FR\FM\10FEN1.SGM 10FEN1

Agencies

[Federal Register Volume 71, Number 28 (Friday, February 10, 2006)]
[Notices]
[Pages 7052-7053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0425]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General 
Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions

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 March 
13, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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.

General Administrative Procedures: Citizen Petitions; Petition for 
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control 
Number 0910-0183)--Extension

    The Administrative Procedures Act (5 U.S.C. 553(e)), provides that 
every agency shall give an interested person the right to petition for 
issuance, amendment, or repeal of a rule. Under part 10 (21 CFR part 
10), Sec.  10.30 sets forth the format and procedures by which an 
interested person may submit to FDA, in accordance with Sec.  10.20 
(submission of documents to the Division of Dockets Management (DDM)), 
a citizen petition requesting the Commissioner of Food and Drugs (the 
Commissioner) to issue, amend, or revoke a regulation or order, or to 
take or refrain from taking any other form of administrative action.
    The Commissioner may grant or deny such a petition, in whole or in 
part, and may grant such other relief or take other action as the 
petition warrants. Respondents are individuals or households, State or 
local governments, not-for-profit institutions, and businesses or other 
for-profit institutions or groups.
    Section 10.33, issued under section 701(a) of the Federal, Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets forth the 
format and procedures by which an interested person may request 
reconsideration of part or all of a decision of the Commissioner in a 
petition submitted under Sec.  10.25 (initiation of administrative 
proceedings). A petition for reconsideration must contain in a well-
organized format a full statement of the factual and legal grounds upon 
which the petition relies. The grounds must demonstrate that relevant 
information and views contained in the administrative record were not 
previously or not adequately considered by the Commissioner. The 
respondent must submit a petition no later than 30 days after the 
decision has been made. However, the Commissioner may, for good cause, 
permit a petition to be filed after 30 days. An interested person who 
wishes to rely on information or views not included in the 
administrative record shall submit them with a new petition to modify 
the decision. FDA uses the information provided in the request to 
determine whether to grant the petition for reconsideration. 
Respondents to this collection of information are individuals or 
households, State or local governments, not-for-profit institutions, 
and businesses or other for-profit institutions who are requesting a 
reconsideration of a matter from the Commissioner.
    Section 10.35, issued under section 701(a) of the act, sets forth 
the format and procedures by which an interested person may request, in 
accordance with Sec.  10.20 (submission of documents to DDM), the 
Commissioner to stay the effective date of any administrative action.
    Such a petition must provide the following information: (1) The 
decision involved; (2) the action requested, including the length of 
time for which a stay is requested; and (3) a statement

[[Page 7053]]

of the factual and legal grounds on which the interested person relies 
in seeking the stay. FDA uses the information provided in the request 
to determine whether to grant the petition for a stay of action. 
Respondents to this information collection are interested persons who 
choose to file a petition for an administrative stay of action.
    Section 10.85, issued under section 701(a) of the act, sets forth 
the format and procedures by which an interested person may request, in 
accordance with Sec.  10.20 (submission of documents to the DDM), an 
advisory opinion from the Commissioner on a matter of general 
applicability. An advisory opinion represents the formal position of 
FDA on a matter of general applicability. When making a request, the 
petitioner must provide a concise statement of the issues and questions 
on which an opinion is requested, and a full statement of the facts and 
legal points relevant to the request. Respondents to this collection of 
information are interested persons seeking an advisory opinion from the 
Commissioner on the agency's formal position for matters of general 
applicability.
    In the Federal Register of November 16, 2005 (70 FR 69574), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Annual Frequency per
       21 CFR Section           No. of Respondents             Response            Total Annual Responses       Hours per Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.30                                            156                          3                        468                         12              5,616
10.33                                             10                          2                         20                         10                200
10.35                                             13                          2                         26                         10                260
10.85                                              2                          1                          2                         16                 32
Total                        .......................  .........................  .........................  .........................              6,108
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1846 Filed 2-9-06; 8:45 am]
BILLING CODE 4160-01-S
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