80 FR 81332 - Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 249 (December 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 249 (December 29, 2015)
| Page Range | 81332-81335 | |
| FR Document | 2015-32685 |
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)] [Notices] [Pages 81332-81335] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32685] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0242] Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs 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 information collection contained in FDA's regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. DATES: Submit either electronic or written comments on the collection of information by February 29, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0242 for ``Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. [[Page 81333]] FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]. 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. Current Good Manufacturing Practice for Positron Emission Tomography Drugs (OMB Control Number 0910-0667)--Extension Positron emission tomography is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product. FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding safety, identity, strength, quality, and purity. The CGMP requirements for PET drugs are issued under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These CGMP requirements are designed to take into account the unique characteristics of PET drugs, including their short half-lives and the fact that most PET drugs are produced at locations that are very close to the patients to whom the drugs are administered. The CGMP regulations are intended to ensure that approved PET drugs meet the requirements of the FD&C Act as to safety, identity, strength, quality, and purity. The regulations address the following matters: Personnel and resources; quality assurance; facilities and equipment; control of components, in-process materials, and finished products; production and process controls; laboratory controls; acceptance criteria; labeling and packaging controls; distribution controls; complaint handling; and recordkeeping. The CGMP regulations establish several recordkeeping requirements and a third-party disclosure requirement for the production of PET drugs. In making our estimates of the time spent in complying with these information collection requirements, we relied on communications we have had with PET producers, visits by our staff to PET facilities, and our familiarity with both PET and general pharmaceutical manufacturing practices. The estimated annual recordkeeping and third- party disclosure burden is based on there being approximately 129 PET drug production facilities. As explained in this document, Table 1 provides an estimate of the annual recordkeeping burdens and Table 2 provides an estimate of the annual third-party disclosure burdens associated with this collection. I. Investigational and Research PET Drugs Section 212.5(b)(2) provides that for investigational PET drugs produced under an investigational new drug (IND) and research PET drugs produced with approval of a Radioactive Drug Research Committee (RDRC), the requirement under the FD&C Act to follow current good manufacturing practice is met by complying with the regulations in part 212 or with USP 32 Chapter 823. We believe that PET production facilities producing drugs under INDs and RDRCs are currently substantially complying with the recordkeeping requirements of USP 32 Chapter 823 (see section 121(b) of the Modernization Act), and accordingly, we do not estimate any recordkeeping burden for this provision. II. Batch Production and Control Records Sections 212.20(c) through (e), 212.50(a) through (c), and 212.80(c) set forth requirements for batch and production records as well as written control records. We estimate that it would take approximately 20 hours annually for each PET production facility to prepare and maintain written production and control procedures and to create and maintain master batch records for each PET drug produced. We also estimate that there will be a total of approximately 221 PET drugs produced, with a total recordkeeping burden of approximately 4,420 hours. We estimate that it would take a PET production facility an average of 30 minutes to complete a batch record for each of approximately 501 batches. Our estimated burden for completing batch records is approximately 32,320 hours. III. Equipment and Facilities Records Sections 212.20(c), 212.30(b), 212.50(d), and 212.60(f) contain requirements for records dealing with equipment and physical facilities. We estimate that it would take approximately 1 hour to establish and maintain these records for each piece of equipment in each PET production facility. We estimate that the total burden for establishing procedures for these records would be approximately 1,939 hours. We estimate that recording maintenance and cleaning information would take approximately 5 minutes a day for each piece of equipment, with a total recordkeeping burden of approximately 40,238 hours. IV. Records of Components, Containers, and Closures Sections 212.20(c) and 212.40(a), (b), and (e) contain requirements on records regarding receiving and testing of components, containers, and closures. We estimate that the annual burden for establishing these records would be approximately 259 hours. We estimate that each facility would receive approximately 36 shipments annually and would spend approximately 10 minutes per shipment entering records. The annual burden for maintaining these records would be approximately 773 hours. V. Process Verification Section 212.50(f)(2) requires that any process verification activities and results be recorded. Because process verification is only required when results of the production of an entire batch are not fully verified through finished-product testing, we believe that process verification will be a very rare [[Page 81334]] occurrence, and we do not estimate any recordkeeping burden for documenting process verification. VI. Laboratory Testing Records Sections 212.20(c), 212.60(a), (b), and (g), 212.61(a) through (b), and 212.70(a), (b), and (d) set out requirements for documenting laboratory testing and specifications referred to in laboratory testing, including final release testing and stability testing. Each PET drug production facility will need to establish procedures and create forms for the different tests for each product they produce. We estimate that it will take each facility an average of 1 hour to establish procedures and create forms for one test. The estimated annual burden for establishing procedures and creating forms for these records is approximately 3,232 hours, and the annual burden for recording laboratory test results is approximately 10,730 hours. VII. Sterility Test Failure Notices Section 212.70(e) requires PET drug producers to notify all receiving facilities if a batch fails sterility tests. We believe that sterility test failures might occur in only 0.05 percent of the batches of PET drugs produced each year. Therefore, we have estimated in Table 2 that each PET drug producer will need to provide approximately 0.25 sterility test failure notice per year to receiving facilities. The notice would be provided using email or facsimile transmission and should take no more than 1 hour. VIII. Conditional Final Releases Section 212.70(f) requires PET drug producers to document any conditional final releases of a product. We believe that conditional final releases will be fairly uncommon, but for purposes of the PRA, we estimated that each PET production facility would have one conditional final release a year and would spend approximately 1 hour documenting the release and notifying receiving facilities. The estimate of one conditional final release per year per facility is an appropriate average number because many facilities may have no conditional final releases while others might have only a few. IX. Out-of-Specification Investigations Sections 212.20(c) and 212.71(a) and (b) require PET drug producers to establish procedures for investigating products that do not conform to specifications and conduct these investigations as needed. We estimate that it will take approximately 1 hour annually to record and update these procedures for each PET production facility. We also estimate, for purposes of the PRA, that 36 out-of-specification investigations would be conducted at each facility each year and that it would take approximately 1 hour to document the investigation, which results in an annual burden of 4,654 hours. X. Reprocessing Procedures Sections 212.20(c) and 212.71(d) require PET drug producers to establish and document procedures for reprocessing PET drugs. We estimate that it will take approximately 1 hour a year to document these procedures for each PET production facility. We do not estimate a separate burden for recording the actual reprocessing, both because we believe it would be an uncommon event and because the recordkeeping burden has been included in our estimate for batch production and control records. XI. Distribution Records Sections 212.20(c) and 212.90(a) require that written procedures regarding distribution of PET drug products be established and maintained. We estimate that it will take approximately 1 hour annually to establish and maintain records of these procedures for each PET production facility. Section 212.90(b) requires that distribution records be maintained. We estimate that it will take approximately 15 minutes to create an actual distribution record for each batch of PET drug products, with a total burden of approximately 16,160 hours for all PET producers. XII. Complaints Sections 212.20(c) and 212.100 require that PET drug producers establish written procedures for dealing with complaints, as well as document how each complaint is handled. We estimate that establishing and maintaining written procedures for complaints will take approximately 1 hour annually for each PET production facility and that each facility will receive approximately one complaint a year and will spend approximately 30 minutes recording how the complaint was dealt with. Table 1--Estimated Annual Recordkeeping Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of No. of records Total annual Average burden per 21 CFR Section recordkeepers per recordkeeper records recordkeeping Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Batch Production and Control Records 129 1.71 221 20............................. 4,420 212.20(c), 212.20(e); 212.50(a), 212.50(b). Batch Production and Control Records 129 501 64,640 0.5 (30 mins.) 32,320 212.20(d) and (e); 212.50(c); 212.80(c). Equipment and Facilities Records 212.20(c); 129 15 1,939 1.............................. 1,939 212.30(b); 212.50(d), 212.60(f). Equipment and Facilities Records 212.30(b), 129 3,758 484,800 0.083 (5 mins.) 40,238 212.50(d); 212.60(f). Records of Components, Containers, and 129 2 259 1.............................. 259 Closures 212.20(c); 212.40(a), 212.40(b). Records of Components, Containers, and 129 36 4,654 0.166 (10 mins.) 773 Closures 212.40(e). Laboratory Testing Records 212.20(c); 129 25 3,232 1.............................. 3,232 212.60(a), 212.60(b), 212.61(a); 212.70(a), 212.70(b), 212.70(d). Laboratory Testing Records 212.60(g); 129 501 64,640 0.166 (10 min.) 10,730 212.61(b); 212.70(d)(2), 212.70(d)(3). Conditional Final Releases 212.70(f)....... 129 1 129 1.............................. 129 Out-of-Specification Investigations 129 36 4,654 1.............................. 4,654 212.20(c); 212.71(a). Reprocessing Procedures 212.71(b).......... 129 1 129 1.............................. 129 [[Page 81335]] Reprocessing Procedures 212.20(c); 129 1 129 1.............................. 129 212.71(d). Reprocessing Procedures 212.20(c); 129 1 129 1.............................. 129 212.90(a). Distribution Records 212.90(b)............. 129 501 64,640 0.25 (15 mins.) 16,160 Complaints 212.20(c); 212.100(a)........... 129 1 129 1.............................. 129 Complaints 212.100(b), 212.100(c).......... 129 1 129 0.5 (30 mins.) 65 ------------------------------------------------------------------------------------------------------------ Total.................................. ................. ................. ................. ............................... 115,435 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of Annual frequency Total annual Hours per 21 CFR section respondents of disclosure disclosures disclosure Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Sterility Test Failure Notices 212.70(e)............ 129 0.25 32 1 32 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this information collection. Dated: December 22, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-32685 Filed 12-28-15; 8:45 am] BILLING CODE 4164-01-P
![81332 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
alternative approach may be used if SUMMARY: The Food and Drug comment, as well as any attachments,
such approach satisfies the Administration (FDA) is announcing an except for information submitted,
requirements of the applicable statute opportunity for public comment on the marked and identified, as confidential,
and regulations. proposed collection of certain if submitted as detailed in
information by the Agency. Under the ‘‘Instructions.’’
III. Electronic Access
Paperwork Reduction Act of 1995 (the Instructions: All submissions received
Persons interested in obtaining a copy PRA), Federal Agencies are required to must include the Docket No. FDA–
of the draft guidance may do so by publish notice in the Federal Register 2013–N–0242 for ‘‘Agency Information
downloading an electronic copy from concerning each proposed collection of Collection Activities: Proposed
the Internet. A search capability for all information, including each proposed Collection; Comment Request; Current
Center for Devices and Radiological extension of an existing collection of Good Manufacturing Practice for
Health guidance documents is available information, and to allow 60 days for Positron Emission Tomography Drugs.’’
at http://www.fda.gov/MedicalDevices/ public comment in response to the Received comments will be placed in
DeviceRegulationandGuidance/ notice. This notice solicits comments on the docket and, except for those
GuidanceDocuments/default.htm. the information collection contained in submitted as ‘‘Confidential
Guidance documents are also available FDA’s regulations on current good Submissions,’’ publicly viewable at
at http://www.regulations.gov. Persons manufacturing practice (CGMP) for http://www.regulations.gov or at the
unable to download an electronic copy positron emission tomography (PET) Division of Dockets Management
of ‘‘Electroconvulsive Therapy (ECT) drugs. between 9 a.m. and 4 p.m., Monday
Devices for Class II Intended Uses: Draft through Friday.
Guidance for Industry, Clinicians, and DATES: Submit either electronic or
written comments on the collection of • Confidential Submissions—To
FDA Staff’’ may send an email request submit a comment with confidential
to CDRH-Guidance@fda.hhs.gov to information by February 29, 2016.
ADDRESSES: You may submit comments
information that you do not wish to be
receive an electronic copy of the made publicly available, submit your
document. Please use the document as follows:
comments only as a written/paper
number 1823 to identify the guidance Electronic Submissions submission. You should submit two
you are requesting. copies total. One copy will include the
Submit electronic comments in the
IV. Paperwork Reduction Act of 1995 following way: information you claim to be confidential
• Federal eRulemaking Portal: http:// with a heading or cover note that states
This draft guidance refers to
www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
previously approved collections of
instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
information found in FDA regulations.
Comments submitted electronically, Agency will review this copy, including
These collections of information are
including attachments, to http:// the claimed confidential information, in
subject to review by the Office of
www.regulations.gov will be posted to its consideration of comments. The
Management and Budget (OMB) under
the docket unchanged. Because your second copy, which will have the
the Paperwork Reduction Act of 1995
comment will be made public, you are claimed confidential information
(44 U.S.C. 3501–3520). The collection of
solely responsible for ensuring that your redacted/blacked out, will be available
information in 21 CFR part 807 subpart
comment does not include any for public viewing and posted on http://
E have been approved under OMB
confidential information that you or a www.regulations.gov. Submit both
control number 0910–0120; the
third party may not wish to be posted, copies to the Division of Dockets
collection of information in 21 CFR 801
such as medical information, your or Management. If you do not wish your
has been approved under OMB control
anyone else’s Social Security number, or name and contact information to be
number 0910–0485; and the collection
confidential business information, such made publicly available, you can
of information in 21 CFR part 820 have
as a manufacturing process. Please note provide this information on the cover
been approved under OMB control
that if you include your name, contact sheet and not in the body of your
number 0910–0073.
information, or other information that comments and you must identify this
Dated: December 18, 2015. information as ‘‘confidential.’’ Any
identifies you in the body of your
Leslie Kux, information marked as ‘‘confidential’’
comments, that information will be
Associate Commissioner for Policy. posted on http://www.regulations.gov. will not be disclosed except in
[FR Doc. 2015–32591 Filed 12–28–15; 8:45 am] • If you want to submit a comment accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P with confidential information that you applicable disclosure law. For more
do not wish to be made available to the information about FDA’s posting of
public, submit the comment as a comments to public dockets, see 80 FR
DEPARTMENT OF HEALTH AND written/paper submission and in the 56469, September 18, 2015, or access
HUMAN SERVICES manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
Food and Drug Administration default.htm.
[Docket No. FDA–2013–N–0242] Written/Paper Submissions Docket: For access to the docket to
Submit written/paper submissions as read background documents or the
Agency Information Collection follows: electronic and written/paper comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Activities: Proposed Collection; • Mail/Hand delivery/Courier (for received, go to http://
Comment Request; Current Good written/paper submissions): Division of www.regulations.gov and insert the
Manufacturing Practice for Positron Dockets Management (HFA–305), Food docket number, found in brackets in the
Emission Tomography Drugs and Drug Administration, 5630 Fishers heading of this document, into the
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
HHS. • For written/paper comments and/or go to the Division of Dockets
submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
ACTION: Notice.
Management, FDA will post your 1061, Rockville, MD 20852.
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![Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices 81335
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Average
No. of No. of records per Total annual burden per
21 CFR Section Total hours
recordkeepers recordkeeper records record-
keeping
Reprocessing Procedures 212.20(c); 129 1 129 1 .................. 129
212.71(d).
Reprocessing Procedures 212.20(c); 129 1 129 1 .................. 129
212.90(a).
Distribution Records 212.90(b) ...................... 129 501 64,640 0.25 (15 16,160
mins.)
Complaints 212.20(c); 212.100(a) .................. 129 1 129 1 .................. 129
Complaints 212.100(b), 212.100(c) ................ 129 1 129 0.5 (30 65
mins.)
Total ........................................................ .............................. .............................. .............................. ..................... 115,435
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
No. of Annual frequency Total annual dis- Hours per disclo-
21 CFR section Total hours
respondents of disclosure closures sure
Sterility Test Failure Notices 212.70(e) 129 0.25 32 1 32
1 There are no capital costs or operating and maintenance costs associated with this information collection.
Dated: December 22, 2015. DATES: Although you can comment on Written/Paper Submissions
Leslie Kux, any guidance at any time, submit either Submit written/paper submissions as
Associate Commissioner for Policy. electronic or written comments by follows:
[FR Doc. 2015–32685 Filed 12–28–15; 8:45 am] February 29, 2016. • Mail/Hand delivery/Courier (for
BILLING CODE 4164–01–P
ADDRESSES: You may submit comments written/paper submissions): Division of
as follows: Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
DEPARTMENT OF HEALTH AND Electronic Submissions Lane, rm. 1061, Rockville, MD 20852.
HUMAN SERVICES • For written/paper comments
Submit electronic comments in the submitted to the Division of Dockets
Food and Drug Administration following way: Management, FDA will post your
[Docket No. FDA–2012–N–1021] • Federal eRulemaking Portal: http:// comment, as well as any attachments,
www.regulations.gov. Follow the except for information submitted,
Medical Device User Fee and instructions for submitting comments. marked and identified, as confidential,
Modernization Act; Notice to Public of Comments submitted electronically, if submitted as detailed in
Web Site Location of Fiscal Year 2016 including attachments, to http:// ‘‘Instructions.’’
Proposed Guidance Development Instructions: All submissions received
www.regulations.gov will be posted to
must include the Docket No. FDA–
the docket unchanged. Because your
AGENCY: Food and Drug Administration, 2015–N–1021 for ‘‘Medical Device User
HHS. comment will be made public, you are Fee and Modernization Act; Notice to
solely responsible for ensuring that your Public of Web site Location of Fiscal
ACTION: Notice.
comment does not include any Year 2016 Proposed Guidance
SUMMARY: The Food and Drug confidential information that you or a Development.’’ Received comments will
Administration (FDA or the Agency) is third party may not wish to be posted, be placed in the docket and, except for
announcing the Web site location where such as medical information, your or those submitted as ‘‘Confidential
the Agency will post two lists of anyone else’s Social Security number, or Submissions,’’ publicly viewable at
guidance documents that the Center for confidential business information, such http://www.regulations.gov or at the
Devices and Radiological Health (CDRH as a manufacturing process. Please note Division of Dockets Management
or the Center) intends to publish in that if you include your name, contact between 9 a.m. and 4 p.m., Monday
Fiscal Year (FY) 2016. In addition, FDA information, or other information that through Friday.
has established a docket, where identifies you in the body of your • Confidential Submissions—To
interested persons may comment on the comments, that information will be submit a comment with confidential
priority of topics for guidance, provide information that you do not wish to be
asabaliauskas on DSK5VPTVN1PROD with NOTICES
posted on http://www.regulations.gov.
comments and/or propose draft made publicly available, submit your
• If you want to submit a comment
language for those topics, suggest topics comments only as a written/paper
with confidential information that you
for new or different guidance submission. You should submit two
documents, comment on the do not wish to be made available to the copies total. One copy will include the
applicability of guidance documents public, submit the comment as a information you claim to be confidential
that have issued previously, and written/paper submission and in the with a heading or cover note that states
provide early input to support manner detailed (see ‘‘Written/Paper ‘‘THIS DOCUMENT CONTAINS
guidances that will be developed. Submissions’’ and ‘‘Instructions’’). CONFIDENTIAL INFORMATION.’’ The
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Document Created: 2015-12-29 10:14:55
Document Modified: 2015-12-29 10:14:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by February 29, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 81332 |
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