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a State or political subdivision concerning a device, or a denial of an application for such exemption.

Subpart D-Preparation of Environmental Documents

review by agency staff. Applicants and petitioners also are encouraged to consult applicable FDA EA guidance documents, which provide additional advice on how to comply with FDA regulations.

(d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may incorporate by reference information presented in other documents that are available to FDA and to the public.

(e) The agency evaluates the information contained in an EA and any public input to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human environment, and whether an EIS or a FONSI will be prepared. The responsible agency official designated in part 5 of this chapter as responsible for the underlying action examines the environmental risks of the proposed action and the alternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are implemented as a condition for approving the selected course of action.

$ 25.40 Environmental assessments.

(a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E) of NEPA, of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted. An EA shall be prepared for each action not categorically excluded in $825.30, 25.31, 25.32, 25.33, or 25.34. The EA shall focus on relevant environmental issues relating to the use and disposal from use of FDA-regulated articles and shall be a concise, objective, and well-balanced document that allows the public to understand the agency's decision. If potentially adverse environmental impacts are identified for an action or a group of related actions, the EA shall discuss any reasonable alternative course of action that offers less environmental risk or that is environmentally preferable to the proposed action. The use of a scientifically justified tiered testing approach, in which testing may be stopped when the results suggest that no significant impact will occur, is an acceptable approach.

(b) Generally, FDA requires an applicant to prepare an EA and make necessary corrections to it. Ultimately, FDA is responsible for the scope and content of EA's and may include additional information in environmental documents when warranted.

(c) Information concerning the nature and scope of information that an applicant or petitioner shall submit in an EA may be obtained from the center or other office of the agency having responsibility for the action that is the subject of the environmental evaluation. Applicants and petitioners are encouraged to submit proposed protocols for environmental studies for technical

25.41 Findings of no significant im

pact. (a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is a document prepared by a Federal agency stating briefly why an action, not otherwise excluded, will not significantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a summary of it and a reference to any other related environmental documents.

(b) The agency official(s) responsible for approving the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusion not to prepare an EIS for the action under consideration.

$ 25.42 Environmental impact state

ments. (a) As defined by CEQ regulations (40 CFR 1508.11) and section 102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed written statement describing:

(1) The environmental impacts of a proposed action;

(2) Any adverse effects that cannot be avoided if the action is implemented;

(3) Alternatives to the action;

(4) The relationship between local short-term uses of the environment and the maintenance and enhancement of long-term productivity; and

(5) Any irreversible and irretrievable commitments of resources that would be involved in the proposed action should it be implemented.

(b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the process for determining the scope of an EIS and provide detailed requirements for the preparation of draft and final EIS's. CEQ format and procedures for preparing EIS shall be followed.

(c) Under the conditions prescribed in 40 CFR 1502.9, the agency will prepare a supplement for a draft or final EIS and introduce the supplement into the administrative record.

$ 25.45 Responsible agency official.

(a) The person designated in part 5 of this chapter as the responsible agency official for the underlying action is responsible for preparing environmental documents or ensuring that they are prepared.

(b) The responsible agency official will weigh any environmental impacts of each alternative course of action, including possible mitigation measures, and will balance environmental impacts with the agency's objectives in choosing an appropriate course of action. The weighing of any environmental impacts of alternatives in selecting a final course of action will be reflected in the agency's record of formal decisionmaking as required by 40 CFR 1505.2.

Subpart E-Public Participation

and Notification of Environmental Documents

$ 25.43 Records of decision.

(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision.

(b) The record of decision shall: (1) State what the decision was;

(2) Identify and discuss alternatives considered by the agency in reaching its decision;

(3) State whether all practicable means to avoid or minimize environmental harm have been adopted, and if not, why not; and

(4) Summarize the program for monitoring and enforcing the practicable means adopted to avoid or minimize the environmental harm.

$ 25.50 General information.

(a) To the extent actions are not protected from disclosure by existing law applicable to the agency's operation, FDA will involve the public in preparing and implementing its NEPA procedures and will provide public notice of NEPA-related hearings, public meetings, and the availability of environmental documents.

(b) Many FDA actions involving investigations, review, and approval of applications, and premarket notifications for human drugs, animal drugs, biologic products, and devices are protected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and 301(j) of the act. These actions are also protected from disclosure under FDA's regulations including part $$ 312.130(a), 314.430(b), 514.11(b), 514.12(a), 601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this chapter. Even the existence of applications for human drugs, animal drugs, biologic products, and devices is protected from disclosure under these regulations. Therefore, unless the existence of applications for human drugs, animal drugs, biologic products, or premarket notification for devices has been made publicly available, the release of the


$ 25.44 Lead and cooperating agencies.

For actions requiring the preparation of an EIS, FDA and other affected Federal agencies will agree which will be the lead agency and which will be the cooperating agencies. The responsibilities of lead agencies and cooperating agencies are described in the CEQ regulations (40 CFR 1501.5 and 1501.6, respectively). If an action affects more than one center within FDA, the Commissioner of Food and Drugs will designate one of these units to be responsible for coordinating the preparation of any required environmental documentation.

environmental document before ap- EA available for public review (includproval of human drugs, animal drugs, ing review by State and areawide inforbiologic products, and devices is incon- mation clearinghouses) for 30 days besistent with statutory requirements fore the agency makes its final deterimposed on FDA. Appropriate environ- mination whether to prepare an EIS mental documents, comments, and re- and before the action may begin, as desponses will be included in the admin- scribed in 40 CFR 1501.4(e). This proceistrative record to the extent allowed dure will be followed when the proby applicable laws.

posed action is, or is closely similar to,

one that normally requires an EIS or $ 25.51 Environmental assessments

when the proposed action is one withand findings of no significant im

out precedent. pact. (a) Data and information that are $ 25.52 Environmental impact stateprotected from disclosure by 18 U.S.C.

ments. 1905 or 21 U.S.C. 331(j) or 360j(c) shall (a) If FDA determines that an EIS is not be included in the portion of envi- necessary for an action involving inronmental documents that is made vestigations or approvals for drugs, public. When such data and informa- animal drugs, biologic products, or detion are pertinent to the environ- vices, an EIS will be prepared but will mental review of a proposed action, an become available only at the time of applicant or petitioner shall submit the approval of the product. Disclosure such data and information separately will be made in accordance with 40 CFR in a confidential section and shall sum- 1506.6 and part 20 of this chapter. The marize the confidential data and infor- EIS will in all other respects conform mation in the EA to the extent pos- to the requirements for EIS's as specisible.

fied in 40 CFR part 1502 and 1506.6(f). (b) FONSI's and EA's will be avail- (b) Comments on the EIS may be subable to the public in accordance with 40 mitted after the approval of the drug, CFR 1506.6 as follows:

animal drug, biologic product, or de(1) When the proposed action is the vice. Those comments can form the subject of a notice of proposed rule- basis for the agency to consider beginmaking or a notice of filing published ning an action to withdraw the apin the FEDERAL REGISTER, the notice proval of applications for a drug, anishall state that no EIS is necessary mal drug, or biologic product, or to and that the FONSI and the EA are withdraw premarket notifications or available for public inspection at premarket approval applications for FDA's Dockets Management Branch. If devices. the respon ble agency official is un- (c) In those cases where the existence able to complete environmental consid- of applications and premarket notificaeration of the proposed action before a tions for drugs, animal drugs, biologic notice of filing of a food or color addi- products, or devices has already been tive petition is required to be published disclosed before the agency approves under the act, and if the subsequent en- the action, the agency will make dilivironmental analysis leads to the con- gent effort (40 CFR 1506.6) to involve clusion that no EIS is necessary, the the public in preparing and implefinal regulation rather than the notice menting the NEPA procedures for of filing shall state that no EIS is nec- EIS's while following its own discloessary and that the FONSI and the EA sure requirements including those listare available upon request and filed in ed in part 20, $312.130(b), 314.430(d), FDA's Dockets Management Branch. 514.11(d), 514.12(b), 601.51(d), 807.95(e),

(2) For actions for which notice is not 812.38(b), and 814.9(d) of this chapter. published in the FEDERAL REGISTER, (d) Draft and final EIS's, comments, the FONSI and the EA shall be made and responses will be included in the available to the public upon request ac- administrative record and will be cording to the procedures in 40 CFR available from the Dockets Manage1506.6.

ment Branch (HFA-305), Food and Drug (3) For a limited number of actions, Administration, 12420 Parklawn Dr., the agency may make the FONSI and rm. 1-23, Rockville, MD 20857.

Subpart F-Other Requirements (2) Coordinate all communications

with foreign governments concerning $ 25.60 Environmental effects abroad environmental agreements and other of major agency actions.

arrangements in implementing the Ex(a) In accordance with Executive ecutive Order. Order 12114, “Environmental Effects Abroad of Major Federal Actions” of PART 26-MUTUAL RECOGNITION January 4, 1979 (44 FR 1957, January 9, OF PHARMACEUTICAL GOOD 1979), the responsible agency official, in MANUFACTURING PRACTICE REanalyzing actions under his or her pro

PORTS, MEDICAL DEVICE QUALgram, shall consider the environmental

ITY SYSTEM AUDIT REPORTS, AND effects abroad, including whether the

CERTAIN MEDICAL actions involve:

DEVICE (1) Potential environmental effects

PRODUCT EVALUATION REPORTS: on the global commons and areas out

UNITED STATES AND THE EUROside the jurisdiction of any nation, e.g.,

PEAN COMMUNITY oceans and the upper atmosphere.

(2) Potential environmental effects Sec. on a foreign nation not participating 26.0 General. with or otherwise involved in an FDA activity.

Subpart A-Specific Sector Provisions for (3) The export of products (or emis

Pharmaceutical Good Manufacturing sions) that in the United States are

Practices prohibited or strictly regulated be

26.1 Definitions. cause their effects on the environment

26.2 Purpose. create a serious public health risk. 26.3 Scope.

(4) Potential environmental effects 26.4 Product coverage. on natural and ecological resources of 26.5 Length of transition period. global importance designated under the 26.6 Equivalence assessment. Executive Order.

26.7 Participation in the equivalence assess(b) Before deciding on any action

ment and determination. falling into the categories specified in

26.8 Other transition activities. paragraph (a) of this section, the re

26.9 Equivalence determination. sponsible agency official shall deter

26.10 Regulatory authorities not listed as

currently equivalent. mine, in accordance with section 2–3 of

26.11 Start of operational period. the Executive Order, whether such ac- 26.12 Nature of recognition of inspection retions may have a significant environ- ports. mental effect abroad.

26.13 Transmission of postapproval inspec(c) If the responsible agency official tion reports. determines that an action may have a

26.14 Transmission of preapproval inspecsignificant environmental effect

tion reports. abroad, the responsible agency official

26.15 Monitoring continued equivalence.

26.16 Suspension. shall determine, in accordance with

26.17 Role and composition of the Joint Secsection 2–4 (a) and (b) of the Executive

toral Committee. Order, whether the subject action calls

26.18 Regulatory collaboration. for:

26.19 Information relating to quality as(1) An EIS;

pects. (2) A bilateral or multilateral envi- 26.20 Alert system. ronmental study; or

26.21 Safeguard clause. (3) A concise environmental review. APPENDIX A TO SUBPART A OF PART 26 LIST

(d) In preparing environmental docu- OF APPLICABLE LAWS, REGULATIONS, AND ments under this subpart, the respon

ADMINISTRATIVE PROVISIONS. sible official shall:


OF AUTHORITIES. (1) Determine, as provided in section

APPENDIX C TO SUBPART A OF PART 26-INDIC2-5 of the Executive Order, whether

ATIVE LIST OF PRODUCTS COVERED BY proposed actions are subject to the ex

SUBPART A. emptions, exclusions, and modification

APPENDIX D TO SUBPART A OF PART 26_CRIin contents, timing, and availability of





Subpart B-Specific Sector Provisions for

Medical Devices

26.78 Agreements with other countries. 26.79 Territorial application. 26.80 Entry into force, amendment, and ter

mination. 26.81 Final provisions.

AUTHORITY: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 3600, 3600, 360e, 360f, 360g, 360h, 360i, 3600, 3601, 360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 2421, 262, 264, 265.

SOURCE: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.

26.31 Purpose. 26.32 Scope. 26.33 Product coverage. 26.34 Regulatory authorities. 26.35 Length and purpose of transition pe

riod. 26.36 Listing of CAB's. 26.37 Confidence building activities. 26.38 Other transition period activities. 26.39 Equivalence assessment. 26.40 Start of the operational period. 26.41 Exchange and endorsement of quality

system evaluation reports. 26.42 Exchange and endorsement of product

evaluation reports. 26.43 Transmission of quality system eval

uation reports. 26.44 Transmission of product evaluation re

ports. 26.45 Monitoring continued equivalence. 26.46 Listing of additional CAB's. 26.47 Role and composition of the Joint Sec

toral Committee. 26.48 Harmonization. 26.49 Regulatory cooperation. 26.50 Alert system and exchange of

postmarket vigilance reports. APPENDIX A TO SUBPART B OF PART 26-REL





§ 26.0 General.

This part substantially reflects relevant provisions of the framework agreement and its sectoral annexes on pharmaceutical good manufacturing practices (GMP's) and medical devices of the “Agreement on Mutual Recognition Between the United States of America and the European Community” (the MRA), signed at London May 18, 1998. For codification purposes, certain provisions of the MRA have been modified for use in this part. This modification is done for purposes clarity only and shall not affect the text of the MRA concluded between the United States and the European Community (EC), or the rights and obligations of the United States or the EC under that agreement. Whereas the parties to the MRA are the United States and EC, this part is relevant only to the Food and Drug Administration's (FDA's) implementation of the MRA, including the sectoral annexes reflected in subparts A and B of this part. This part does not govern implementation of the MRA by the EC, which will implement the MRA in accordance with its internal procedures, nor does this part address implementation of the MRA by other concerned U.S. Federal agencies. For purposes of this part, the terms “party” or “parties,” where relevant to FDA's implementation of the MRA, should be considered as referring to FDA only. If the parties to the MRA subsequently amend or terminate the MRA, FDA will modify this part accordingly, using appropriate administrative procedures.

Subpart C-"Framework“ Provisions

26.60 Definitions. 26.61 Purpose of this part. 26.62 General obligations. 26.63 General coverage of this part. 26.64 Transitional arrangements. 26.65 Designating authorities. 26.66 Designation and listing procedures. 26.67 Suspension of listed conformity as

sessment bodies. 26.68 Withdrawal of listed conformity as

sessment bodies. 26.69 Monitoring of conformity assessment

bodies. 26.70 Conformity assessment bodies. 26.71 Exchange of information. 26.72 Sectoral contact points. 26.73 Joint Committee. 26.74 Preservation of regulatory authority. 26.75 Suspension of recognition obligations. 26.76 Confidentiality. 26.77 Fees.

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